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

Model Number	GIF-XTQ160
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.In addition to the phenomena identified in b5, the following phenomena were identified during the evaluation: water tightness was lost due to a cut on switch one; up/down knob could not be locked securely due to wear of lock engagement lever; channel cleaning brush could not be inserted smoothly due to a crack on the channel mount unit; forceps channel port had a scratch; the suction cylinder had no color; switch two had a cut; the scope cover was deformed; the electrical connector had corrosion due to water leakage; water tightness was lost due to damage on the channel tube; the insulation resistance value at distal end did not meet the standard value due to adhesive peeling on the bending section cover; the bending angle in down direction did not meet the standard value due to wear of the angle wire; the bending angle in right direction did not meet the standard value due to wear of the angle wire; the channel tube had a scratch; the image guide protector had a cut; the plastic distal end cover had a scratch; the objective lens had a chip; the adhesive around the objective lens had corrosion; the light guide lens had a crack; the adhesive around the light guide lens had corrosion; the light guide lens had a scratch; the bending tube was deformed; the adhesive on the bending section cover had a crack; the connecting tube was deformed; the braids of the universal cord were exposed; and the protector of the universal cord on the control section side had a cut.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the proximal end to handle was bent on the gastrointestinal videoscope.The device was returned for evaluation.During the device evaluation, white foreign remains were found in the air/water tube and air/water cylinder.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
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 foreign material could not be identified, nor the root cause of it.The event can be detected/prevented in accordance, with the following instructions for use: evis exera gif type xtq160, operation manual chapter 3: preparation and inspection.Evis exera gif type xtq160, reprocessing manual chapter 3: cleaning, disinfection and sterilization procedures.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: 18310157
• Report Number: 9610595-2023-19318
• Device Sequence Number: 12441911
• Product Code: FDS
• UDI-Device Identifier: 04953170339837
• UDI-Public: 04953170339837
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

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: 11/27/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2006
• 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