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

Model Number	GIF-XTQ160
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the distal end of the gastrointestinal videoscope was damaged.The device was returned and an evaluation of the returned device revealed presence of foreign material in the forceps channel port.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There were no reports of patient harm associated with the event.
Additional Manufacturer Narrative
An evaluation of the returned device could not confirm the customer allegation ¿distal end was damaged¿.There were few additional findings.Due to damage on switch, water tightness was lost.Due to wear of forceps elevator lever, up/down knob could not be locked securely.Discoloration was noted in the following parts- air/water cylinder, suction cylinder, scope connector cover, control unit, grip, switch box and right/left knob.Due to a cut on heat shrinking tube of forceps elevator lever, expected insulation capacity could not be obtained.Scope connector and electrical connector had corrosion due to water leakage.Plate has corrosion due to water leakage.Due to damage on bending section cover, insulation resistance value at distal end does not meet the standard value.Due to wear of angle wire, the play of up/down knob was out of the standard value.Due to wear of angle wire, the play of right/left knob was out of the standard value.The distal end cover had a burn.Connecting tube had a scratch.Universal cord was deformed.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is available.
Additional 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 reported event is unable to be determined.However, the cause of the event is likely due to insufficient or inadequate reprocessing.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: 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: 16654461
• Report Number: 9610595-2023-05368
• Device Sequence Number: 6521684
• Product Code: FDS
• UDI-Device Identifier: 04953170339837
• UDI-Public: 04953170339837
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K011151
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: GIF-XTQ160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 06/20/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 06/16/2023; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown