Surgical Holdings: Celebrates the Success of the Rigid Endoscope Repair Workshop

In 2016, Southend-based Surgical Holdings opened its new Rigid Endoscope Repair Workshop with the objective of offering the highest quality third party repair at a competitive price. All major brands are repaired by skilled in-house technicians who have been repairing scopes for 15 years.

• Surgical Holdings offers a third party scope repair, as mentioned in the MHRA ‘Managing Medical Devices – April 2016’
• Surgical Holdings is ISO 13485 accredited and accredited to the Medical Device Directive 93/42/EEC for orthopaedic implant manufacturer
• Surgical Holdings stocks parts for manufacturers such as Storz, Wolf, Olympus, Aesculap, and all parts have full traceability through its ISO 13485 accredited quality system
• Reverse engineering is utilised, through Surgical Holdings’ engineering workshop to allow the company to also manufacture parts for the latest models of scopes where required
• All repairs include a full scope strip down and inspection by skilled technicians. Scopes are straightened and the entire endoscope is cleaned prior to re-assembly. Following repair, each endoscope is quality tested, packed and returned with a detailed customer report
• CE marking integrity is maintained.

Background

Rod-lens (or rigid) endoscopes were invented by British physicist Harold Hopkins, one of the foremost authorities in the field of optics, and ‘opened the door’ to modern key-hole surgery.

After inventing zoom lenses, coherent fibre optics and fiberscopes (flexible endoscopes), Hopkins patented his lens system for the rod-lens endoscope in 1959. The patent was bought by Karl Storz in 1967, who was already producing instruments for ENT specialists and began to produce endoscopic instruments with a tremendously brilliant image and superb illumination thanks to Hopkins’ invention. This was the start of a long and productive partnership between Hopkins and Storz.

Uses

The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body. Unlike many other medical imaging techniques, endoscopes can be inserted directly into the organ.

Endoscopes can be inserted into the body through a natural opening or through a small cut (incision) made in the skin when keyhole surgery is being carried out.

There are three main reasons for carrying out an endoscopy:

Investigation: If an individual is experiencing vomiting, abdominal pain, breathing disorders, stomach ulcers, difficulty swallowing, or gastrointestinal bleeding, for example an endoscope can be used to search for a cause.

Confirmation of a diagnosis: Endoscopy can be used to carry out a biopsy to confirm a diagnosis of cancer or other diseases.

Treatment: An endoscope can be used to treat an illness directly; for instance, endoscopy can be used to cauterize (seal using heat) a bleeding vessel or remove a polyp.

Endoscopy is useful for investigating many systems within the human body; rigid endoscopes are particularly used for:

• Ear, nose and throat: nose (Rhinoscopy), ear (Otoscopy)
• Urinary tract: Cystoscopy
• Female reproductive tract (gynoscopy): Uterus (hysteroscopy).
• Through a small incision: Abdominal or pelvic cavity (laparoscopy), interior of a joint (arthroscopy), organs of the chest (thoracoscopy and mediastinoscopy)

Types of Rigid Endoscope

Rigid and semi-rigid endoscopes have a stainless steel body and glass rod lenses or fibre optic lenses allows the surgeon visualisation of the structure or organ. Visualisation is allowed by the degree of the lens and not the flexibility of the scope.

The rigid endoscope comes in a variety of view angles: 0 degrees for forward viewing, 30 and 45 degrees for forward oblique views, 70 degrees for lateral views and 120 degrees for retrograde views.

Parts of an Endoscope

An endoscope can consist of:

• A rigid or flexible tube
• A light delivery system to illuminate the organ or object under inspection. The light source is normally outside the body and the light is typically directed via an optical fibre system
• A lens system transmitting the image from the objective lens to the viewer, typically a relay lens system in the case of rigid endoscopes or a bundle of fiberoptics in the case of a fiberscope
• An eyepiece. Modern instruments may be video scopes, with no eyepiece. A camera transmits an image to a screen for image capture
• An additional channel to allow entry of medical instruments or manipulators

Repairing Rigid Endoscopes

With so many complex parts, endoscopes often need repairs for both normal wear and tear and external damage.

Normal wear and tear

• Autoclaving: expansion/contraction, friction between shaft, lenses and spacers
• Insertion/retraction from a work shaft: bending, dents
• Light source: discolouration of adhesive layers and fibre glue

External Damage

• Mechanical: bends, dents, cracks
• Shaver/lithotripter: damage to shaft, distal window, fibres, fluid leakage
• Heat: tip, fibres, distal window, leakage
• Shock: extreme damage to lens system and construction usually due to dropping

Repairing Rigid Endoscopes

In 2016, Surgical Holdings opened its new Rigid Endoscope Repair Workshop with the objective of offering the highest quality third party repair at a competitive price. All major brands are repaired by skilled in-house technicians who have been repairing scopes for over 25 years.

The workshop utilises all the latest technologies used in optical repair, including laser welding and the latest soldering techniques. Surgical Holdings is ISO 13485 accredited and accredited to the Medical Device Directive 93/42/EEC for orthopaedic implant manufacture, a higher level of certification to which we also apply the same principles during our endoscope repair. Third party repairs are highlighted in MHRA advice around device maintenance.

On arrival at the workshop in Southend, the endoscope is booked into Surgical Holdings’ database for full traceability. It then goes through a rigorous inspection of all components. Trained technicians work through the repair, creating a report and testing on calibration quality devices to ensure important factors such as field of view, are correct to the OEM original angles.

The definition of CE marking is a symbol applied to products to indicate that they conform with relevant EU directives regarding health and safety; our repairs are tested and checked by experienced endoscope repair technicians and measured on quality checking devices to ensure they still conform to the Medical Device Directive and are safe to use. We provide a report to confirm what has been carried out.

Surgical Holdings stocks parts for manufacturers such as Storz, Wolf, Olympus, Aesculap and always uses the correct parts for a specific model, no generic components are used. Any manufacturers or CE marks are retained. All parts have traceability through its ISO 13485 accredited quality system. OEM test procedures are then carried out on an OEM test bench on each repaired scope to determine field of view – focal length etc.

Surgical Holdings can also manufacture parts for the latest models of scopes through reverse engineering in its workshop. The company follows the manufacturer’s optical specification where possible to ensure the original quality of the scope is maintained.

On completion, the endoscope is packed and sent with a detailed customer report. Surgical Holdings offers an 18-month guarantee on its endoscope repair service.

Thank you for reading the above blog. If you have any questions, please do not hesitate to contact us on: 01702 602050.

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