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Recall Observatory FDA recall evidence

Device product

PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE

Z-0419-2024

October 16, 2023

Class II

Product summary

Firm
Aizu Olympus Co., Ltd.
Event
Event 93335
Status
Ongoing
Classification
Class II
Quantity
24 incorrectly repaired units
Official record key
device-enforcement:Z-0419-2024

Official wording

Reason: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

Code information: UDI-DI 04953170305191 Serial Numbers 2302719, 2516751

Distribution pattern: Domestic distribution to FL, KY, MA, NJ, NY, and PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.