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

Model Number PCF-H190DL

Device Problem Mechanical Jam (2983)

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

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

The device is returned, and an evaluation completed for it.Upon inspection and testing, it was observed that right angle wire was frayed with strands sticking up at the control body side.Other observations for the device: play of up/down knob; distal end plastic cover has a crack; objective lens has glue peeling; light guide lens has crack and glue peeling; adhesive of distal end rubber coating (a-rubber) has a crack; control body has customer label that customer wants retained; and insertion tube has a minor surface crack.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

As reported for this event by the customer, during reprocessing the device angulation hand dials were found to be broken.There is no patient involvement.

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, it is likely that the angulation control knobs malfunctioned and broke due to excessive stress applied such as: repeated manipulation of angulation at procedure, manipulation of angulation with endo therapy accessories being inserted, excessive stress under angulation, repeated looping the insertion section, etc.The event can be prevented by following the instructions for use which state: "3.3 inspection of the endoscope -inspection of the bending mechanisms: warning if the movement of the up/down angulation lock, right/left angulation lock, and the angulation control knobs is loose and/or not smooth, or the bending section does not angulate smoothly, the bending mechanism may have an irregularity.In this case, do not use the endoscope because it may be impossible to straighten the bending section during an examination.Ifu (operation manual) states about manipulation of angulation as follows: 4.2 insertion -angulation of the distal end: caution avoid forcible or excessive angulation as this imposes stress on the wire controlling the bending section.This may cause stretching or tearing of the wire, which could impair the movement of the bending section." 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: 16412698
• MDR Text Key: 310504909
• Report Number: 9610595-2023-02893
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170363672
• UDI-Public: 04953170363672
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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