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

Model Number GIF-HQ190

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 07/28/2023

Event Type  malfunction  

Event Description

The customer reported that during an unspecified diagnostic procedure using the evis exera iii gastrointestinal videoscope, a piece of a broken cleaning brush had popped out of the suction port of the scope.It was reported that the same scope may have been used for a procedure on (b)(6) 2023 where the brush may have been in the suction channel at the time of the procedure.There have been no reports of patient or user harm due to the event.This report is being submitted for the procedure on (b)(6) 2023, whereby the scope may have been used with the broken cleaning brush.The procedure whereby the broken brush was found is being reported in the mdr for patient identifier (b)(6).

Manufacturer Narrative

In addition to b5, additional information was received from the reporter: the endoscope had passed reprocessing before the first procedure without any errors from the evotech cleaner/reprocessor.The endoscope had been used on (b)(6) 2023 and immediately after the procedure with the "broken brush", it was cleaned with a new cleaning brush which passed through all channels and effectively completed the evotech cycle without any errors.The scope was taken to the washroom where it was soaked in high level disinfectant and a cleaning brush inserted through all the channels, and then ran through the evotech for the final step of disinfectant.All accessories were without any abnormality.The endoscope was then hung in the scope cabinet after disinfection cycle.There did not appear to be any disruptions in the flow and/or suction prior to the start of the case on (b)(6) 2023, and there were no interruptions during the procedure, and there was no visualization of debris during the procedure.Biopsies were taken as well without any issues.Disposable buttons used in the procedure had no issues intra-operatively.The device was returned to olympus for evaluation.Inspection and testing found the following: the plastic distal end cover insulation had dents and scratches.The switch button 1 had a cut.Angulation in the up direction is low and out of specification.The play on the control knob was loose on the up/down right/left movement.The distal end plastic cover had scratches.The objective lens edge had a chip.The light guide lens had a chip and crack x1.The bending section cover had been cut.The bending section cover had cracks on both sides.The insertion tube had a cut on the boot.The investigation is ongoing, and 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 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 root cause of the foreign material (broken brush) was insufficient cleaning.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): 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: 17723544
• MDR Text Key: 323116002
• Report Number: 9610595-2023-13102
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

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: 08/22/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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