MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 22.5 FR.; RIGID ENDOSCOPE SHEATH

Model Number	WA22810A
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the device inspection, that the outer sheath exhibited numerous spark marks at the tip.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned and the evaluation found that there were numerous spark marks at the tip, and the edge of the outer sheath was reflected in the image underwater.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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.It has been over 1 year since the subject device was manufactured.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.Based on the results of the investigation, and although we could not determine the root cause of the event, it is likely the defect was caused by incorrect handling and user not following instructions for use (ifu).Olympus will continue to monitor field performance for this device.

• Brand Name: OUTER SHEATH, 22.5 FR.
• Common Device Name: RIGID ENDOSCOPE SHEATH
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19160087
• Report Number: 9610773-2024-01080
• Device Sequence Number: 12626617
• Product Code: GCP
• UDI-Device Identifier: 04042761051729
• UDI-Public: 04042761051729
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: WA22810A
• Device Lot Number: 22X02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WA22850A SERIAL NO.(B)(6).; WA2T43WA SERIAL NO.(B)(6).
• Patient Sex: Unknown