MAUDE Adverse Event Report: KARL STORZ SE & CO. KG RESECTOSCOPE SHEATH, 26 FR.

Model Number	26040SL
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 during a medical surgery, there was a rupture of the end part of the resector liner (ceramic part) within the bladder cavity.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
Result of investigation: as the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.Based on the available information, the failure description and similar complaints, the root cause of the ceramic tip breaking can be attributed to various factors: repeated applications can cause material fatigue, resulting in microcracks that ultimately lead to breakage.Excessive user force on the ceramic tip can cause microcracks to form, which expand over time and eventually lead to breakage.This is consistent with the warning statements regarding overloading and careless handling of ceramic components.If the ceramic tip was already damaged prior to use or improperly reprocessed, this could have contributed to the weakening of the material.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: RESECTOSCOPE SHEATH, 26 FR.
• Common Device Name: RESECTOSCOPE 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: 21231211
• Report Number: 9610617-2025-00041
• Device Sequence Number: 21013074
• Product Code: HIH
• UDI-Device Identifier: 04048551229910
• UDI-Public: 04048551229910
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/09/2025

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: 26040SL
• Device Catalogue Number: 26040SL
• Device Lot Number: A0023Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 04/09/2025
• 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