MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III COLONOVIDEOSCOPE

Model Number PCF-HQ190L

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the colonovideoscope clip was pushed out of the scope during reprocessing.After cleaning the scope, a borescope was used.Internal channel was noted as having ¿black spots¿ and ¿tearing or peeling¿ of internal coating.There were no reports of patient harm or impact associated with this event.

Manufacturer Narrative

The device was returned for evaluation and the following findings were revealed: internal failure of channel, which was consistent with insufficient or incorrect reprocessing of the device.In addition, it was noted that there were tears and burn mark in channel; labels were not properly affixed; plastic distal end cover insulation was cracked; pinhole on switch (3); all directions of angulation out of specification; control knob grinding; control knob movement/play; distal end plastic cover dented/scratched; objective lens and light guide lens edge chipped/worn glue; bending section cover glue cracked; insertion tube cut on boot/scratched not catching; and light guide tube scratched.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the foreign material could not be identified nor the root cause of it although it can be presumed that it was an error in reprocessing.Three attempts were performed to obtain additional information, but no response was received from the customer.The event can be detected/prevented in accordance with the following instructions for use: gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection.Gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18176327
• MDR Text Key: 328611446
• Report Number: 9610595-2023-17740
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170416118
• UDI-Public: 04953170416118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-HQ190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1