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

Model Number GIF-Q160Z

Device Problems Device Reprocessing Problem (1091); Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Device return evaluation was completed.The customer complaint was confirmed.Cleaning brush insertion check performed and found the forceps cannot be inserted nor removed.Additionally, service repair noted the channel-mount unit is clogged.Furthermore, the following findings during inspection were noted on the device: insertion part -light guide bundle -fiber breakings noted.Insertion part -bending tube - shorten (distorted).Insertion part - connecting tube - scratch noted.Control unit -air /water nut - painting peel off.Control unit -suction cylinder nut - painting peel off.Universal cord -wrinkled.Universal cord - suction tube -failed (insertion part / distal end /biopsy channel )noted clogged.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer reported with an issue of cleaning brush insertion issue.Forceps cannot be inserted nor removed.The issue occurred during reprocessing.There was no patient harm, no user injury reported due to the event.Device evaluation found the channel-mount unit is clogged.This report is being submitted for clogged channel-mount found on device evaluation.

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 19 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the foreign material was part of the biopsy valve.The root cause of clogged channel-mount unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15207685
• MDR Text Key: 303050427
• Report Number: 9610595-2022-00788
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K011151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

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-Q160Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2003
• 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