MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. GASTROINTESTINAL VIDEOACOPE; GASTROINTESTINAL VIDEOSCOPE

Model Number	GIF-LV1
Medical Device Problem Code	Failure to Clean Adequately (4048)
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, the gastrointestinal videoacope had reduced angulation.The issue was found during general routine inspection.The device was returned for evaluation.During the device evaluation, it was found that the bending section cover had foreign objects.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
The device was returned to olympus for evaluation and the evaluation found that the universal cord had discoloration, grip had a scratch, suction cylinder had a scratch and was shaved, water tightness was lost due to damage on channel tube, bending angle in down direction did not meet the standard value due to wear of angle wire, suction cover was shaved, grip had discoloration, switch box had discoloration, distal end had a dent, connecting tube had a scratch, water removal ability did not meet the standard value due to clogging of nozzle, adhesive on bending section cover was detached, and distal end had a scratch.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.
Additional Manufacturer Narrative
Correction to g3 of the previous medwatch report, 9610595-2023-19975 (01).The aware date should be 27-jan-2024.
Additional Manufacturer Narrative
Upon further review by the legal manufacture, it was determined that the reportable malfunction included in the initial medwatch report with mfr# 9610595 2023 19975 was erroneous (4048 - failure to clean adequately).Additional review revealed that the reported device problem is not a malfunction reportable product failure.Per the legal manufacturer, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.Corrections to medwatch fields: b1: product problem incorrectly selected.H1: malfunction incorrectly selected.H6 code 4048 - failure to clean adequately was incorrectly selected.

• Brand Name: GASTROINTESTINAL VIDEOACOPE
• 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: 18365652
• Report Number: 9610595-2023-19975
• Device Sequence Number: 8014428
• Product Code: FDS
• UDI-Device Identifier: 04953170312373
• UDI-Public: 04953170312373
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111756
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2024

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-LV1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 12/21/2023; 02/07/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/05/2024; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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