MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION; A22014A

Model Number	A22014A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the ceramic head of the resection sheath was broken.The event was observed during service/maintenance.There were no reports of patient involvement.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: d8, d9, h2, h3 and h6.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection and the reported failure was confirmed.Based on the results of the investigation, it is likely that stress led to the malfunction.However, a root cause could not be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.

• Brand Name: RESECTION SHEATH, 24 FR., INTERMITTENT IRRIGATION
• Common Device Name: A22014A
• 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21210315
• Report Number: 9610773-2025-00608
• Device Sequence Number: 14432321
• Product Code: HIH
• UDI-Device Identifier: 04042761020893
• UDI-Public: 04042761020893
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K931995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: A22014A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/04/2025
• 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