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

Model Number GIF-H180

Device Problem Mechanical Problem (1384)

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

Event Date 06/25/2023

Event Type  malfunction  

Event Description

The customer reported to olympus the evis exera ii gastrointestinal videoscope exhibited an angulation locking issue.The user observed the ¿little wheel clicks and locks¿ during preparation for use.There were no reports of patient harm or impact associated with this event.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's reported issue was not confirmed.During the evaluation, it was determined that: biopsy channel had a leak; bending section cover (a-rubber)had a leak; plastic distal end cover (c-cover) insulation was below threshold; light guide rod lens (2x) was cracked; charged coupled device (ccd) cover lens was scratched; distal end lens glue (2x) had discoloration; charged coupled device (ccd) cover lens had discoloration; plastic distal end cover (c-cover) had a sharp edge (snag); bending section cover (a-rubber) was porous; bending tube was deformed; connecting tube was scratched pocket-pouch; connecting tube protector was shaved; scope cover was scratched; suction cylinder nut painting was peeling off; switch box unit was scratched; color ring was cracked; universal cord was scratched; connector had chemical damage; the control unit had reduced angulation and play; charged coupled device (ccd)-unit had white dots; and air water channel was below the specification value.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

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, the root cause of the suggested event could not be concluded.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 17396936
• MDR Text Key: 320029898
• Report Number: 9610595-2023-10625
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170202285
• UDI-Public: 04953170202285
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

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-H180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2009
• 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