MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-HQ190

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device inspection found control body looseness, becomes unstable to move.In addition, the d/e plastic (distal end) observed with deep dents.The ob lens (objective lens) found chip on edge.Light guide lens has chip , cracked glue on a-rubber was noted.Play , loose observed on control knob and peeling on labels were observed.Angulation was found low.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported, the angulation does not bend.The issue found during reprocessing.There is no patient involvement associated on this event.Device return evaluation found the moving part in the bcu (body control unit) the angle knob becomes unstable to move.This report is being submitted for bcu unit becomes unstable to move.

Event Description

A user facility reported to olympus that during reprocessing their evis exera iii gastrointestinal videoscope angulation does not bend.Upon inspection and testing of the customer returned device, it was observed that the moving part in the bcu (body control unit) the angle knob becomes unstable to move.This report is being submitted for the malfunction found during evaluation.There was no harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to g3, b5 of the initial medwatch.The aware date should be 26-jan-2022.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.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 root cause of the reported event is unable to be confirmed.Therefore, the cause of the event is unable to be determined.The event can be detected by following the instructions for use (ifu) which state: 3.3 inspection of the endoscope_ inspection of the bending mechanisms_ inspection for smooth operation ¿-straighten the bending section.¿ ¿-move both the up/down and right/left angulation locks all the way in the ¿f¿ direction to confirm that their respective locks are released.¿ ¿-turn the up/down and right/left angulation control knobs slowly in each direction until they stop and return them to their respective neutral positions.Confirm that the bending section angulates smoothly and correctly, that maximum angulation can be achieved, and that the bending section returns to its neutral position.¿ ¿-when the up/down and right/left angulation control knobs are turned to their respective neutral positions, confirm that the bending section returns smoothly to an approximately straight condition." if additional information becomes available, this report will be supplemented accordingly.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13587167
• MDR Text Key: 296470001
• Report Number: 8010047-2022-03452
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305276
• UDI-Public: 04953170305276
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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