MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-HQ290

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned for evaluation.Scoring was visible on the insertion tube; the scoring extends along the length of the insertion tube from the proximal end to the distal end.Other findings were: worn light cover glasses adhesive, worn optical cover glass adhesive and worn distal end adhesive.There was a hole in the switch button #1, light guide tube had minor delamination, minor fluid ingress in scope connector, play evident on up/down and left/right angle play and scratched insertion tube (bite marks).The device was leaked tested prior to repair, and the device was not leaking.Technical evaluation has confirmed the customer specified fault.The presence of the mechanical damage highlights a customer handling issue.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that in the middle of a gastro procedure, the patient grabbed the scope and it got stuck in the patient's mouth/esophagus.The physician had the scope in retroflex position in the stomach when it happened.The patient had to go to the main theatre to use another scope to get the scope out and it scratched and damaged the insertion tube.There was a clinically relevant procedure delay.As reported, broken parts were retrieved from patient with another scope.The scope was never locked in the j maneuver, as reported.The intended procedure was completed with intervention procedure.There were no reports of further patient or user harm associated with this event.

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.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, since no further event details could be obtained from the customer, the root cause of this event could not be determined.This supplemental report includes information added to d8 and h4.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ELITE 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: 17007358
• MDR Text Key: 316000881
• Report Number: 9610595-2023-08072
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-HQ290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• 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
• Patient Outcome(s): Required Intervention