MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH INNER SHEATH, FOR A4740; INNER SHEATH FOR RESECTOSCOPES

Model Number	A4741
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the sheath had the ceramic tip damaged.The issue was found during preparation for use.There were no reports of patient harm as a result of this event.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record could not be performed, the lot number remains unknown since the instrument is too worn and the inscription of the lot number could not be recognized.Despite best efforts, the lot/serial number for the affected device could not be obtained.Therefore, a dhr review could not be performed.The customer reported that the device¿s outer sheath had a damaged ceramic tip.Since the reported device had not been returned to olympus, no results of a physical device inspection are available.Additionally, the reported fault pattern indicates a cause most likely attributable to excessive force, but a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: INNER SHEATH, FOR A4740
• Common Device Name: INNER SHEATH FOR RESECTOSCOPES
• 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: 19473568
• Report Number: 9610773-2024-01389
• Device Sequence Number: 15221855
• Product Code: HIH
• UDI-Device Identifier: 04042761006514
• UDI-Public: 04042761006514
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K897003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: A4741
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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