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

Model Number	GIF-XP150N
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
Additional Manufacturer Narrative
The device was returned and the evaluation found no reportable malfunctions aside from the allegation reported in b5.Should additional relevant information become available, a supplemental report will be submitted.Although the customer has been trained as per olympus medical systems india (omsi) training ifu, customer should performs pre-clean steps without any delay, there is a possibility that delay happens sometimes at customer end in precleaning.So, the device might be not correctly reprocessed at the time of pickup of the device for inspection at the omsi workshop.
Event or Problem Description
It was observed that during the device evaluation, the gastrointestinal videoscope exhibited foreign objects in the following components: nozzle, plastic distal end cover, adhesive around objective and light guide lenses, bending section cover, connecting tube, and up,down, and right, left knob.T here were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, olympus confirmed foreign material came out of the device, but the type of the material or root cause cannot be identified.The event can be detected/prevented by following the instructions for use which state: ifu states that detection method in gif type xp150n operation manual chapter 3 preparation and inspection.Ifu states that preventive measure in gif type xp150n reprocessing manual chapter 3 cleaning, disinfection and sterilization procedures.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 18712028
• Report Number: 9610595-2024-03257
• Device Sequence Number: 7111141
• Product Code: FDS
• UDI-Device Identifier: 04953170229442
• UDI-Public: 04953170229442
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: Other
• Device Model Number: GIF-XP150N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2020
• 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