MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH F. RESECT. SHEATH, 15 FR.

Model Number	26053CB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id:(b)(4).
Event or Problem Description
It was reported that the "ceramic resectoscope sheath broke" during procedure.The procedure was completed successfully without any surgical delay.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: as the electrode has not been returned a final determination of the root cause is not possible.In similar cases with the same product, excessive force during application caused the electrode wire to break and creating a shortcut.The expiry date of 011050-10 batch 812076 is 31.07.2023 - the event happened at the 12.09.2024 -> 14 month after expiration.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH F. RESECT. SHEATH, 15 FR.
• Common Device Name: INNER SHEATH F. RESECT. SHEATH
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 20315389
• Report Number: 9610617-2024-00340
• Device Sequence Number: 8005670
• Product Code: HIH
• UDI-Device Identifier: 04048551410479
• UDI-Public: 04048551410479
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2024

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: 26053CB
• Device Catalogue Number: 26053CB
• Device Lot Number: PM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown