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Regulatory Advisory: Third-Party Repairs on Olympus Endoscopes
Important Information for G.I. Lab Personnel/Hospitals Using Olympus Endoscopes
PLEASE READ THIS ADVISORY IF YOUR FACILITY USES THIRD-PARTY VENDORS TO REPAIR YOUR OLYMPUS ENDOSCOPES
It is likely your scopes are being modified from their original factory specifications if your facility is utilizing third-party vendors to repair your Olympus endoscopes. Olympus cannot ensure the functionality of Olympus equipment that has been disassembled, repaired, altered, changed or modified by third-party vendors. For this reason, Olympus does not recommend the use of non-Olympus parts or third-party repair vendors for Olympus medical equipment, and we do not sell our parts, materials, processes or proprietary tools and equipment to third-party vendors.
Impact on clinical performance
One of the most significant third-party modifications that has become increasingly prevalent is the replacement of the Olympus insertion tube with a non-Olympus part. To date, every sample of third-party insertion tubes examined by Olympus revealed a substantial difference in design, materials and workmanship in comparison to the advanced properties of the Olympus insertion tube. When these aftermarket insertion tubes were tested by Olympus, there was a marked degradation in overall scope handling, performance and durability. Talk to your physicians to see if they have encountered any of the following difficulties during colonoscopy procedures:
- A change in the performance of the scope’s insertion tube – either feeling too rigid or floppy or lacking sufficient column strength to evenly rotate down the length of the tube
- Longer procedure times
- Difficulty navigating the colon or reaching the cecum
- Increased patient discomfort and/or the need for additional patient medication
Endoscope handling characteristics
The architecture of an Olympus insertion tube represents more than 30 years of clinical engineering design and advancement, based on insights from endoscopists around the world, to deliver superior performance and enhance patient safety. Olympus has designed and developed the handling characteristics of an Olympus endoscope to reflect the anatomical conditions and challenges for the procedure:
- For easy insertion, the insertion tube must be capable of accurately transmitting the subtle movements and torque applied by the endoscopist, with any rotation applied to the proximal portion being transferred to the distal end in a precise 1:1 ratio.
- The insertion tube needs to conform easily to the tortuous anatomy of the patient, yet have sufficient column strength to prevent buckling when the proximal end is pushed, and ample elasticity to return into a straightened condition when it is pulled back.
 Interior architecture of an Olympus insertion tube
Exterior polymer layer of an Olympus insertion tube
For more information
There are many differentiating mechanical and imaging features engineered into Olympus flexible endoscopes, and the insertion tube represents just one of the key components of this product. There are also some subtler differences between Olympus and third-party parts and repair processes on other endoscope components that are equally important. If you would like more details, please speak to your sales representative or contact Olympus at 800-537-5739 extension 5290. Thank you for your attention to this important matter.
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