MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH RESECTOSCOPE SHEATH,22CHARR

Model Number	26055CB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is provided in section d10.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, during resection of fibroid, loop became damaged and the inner sheath ceramic beak was subsequently damaged, has dark markings on inside, the ceramic beak cracked but did not detach inside the patient.Thus, they did not x-ray.No death or (unanticipated) serious deterioration in state of health reported.
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).

• Brand Name: INNER SHEATH RESECTOSCOPE SHEATH,22CHARR
• Common Device Name: INNER SHEATH RESECTOSCOPE SHEATH,22CHARR
• 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: 24378985
• Report Number: 9610617-2026-00085
• Device Sequence Number: 21458866
• Product Code: HIH
• UDI-Device Identifier: 04048551275597
• UDI-Public: 04048551275597
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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: 26055CB
• Device Catalogue Number: 26055CB
• Device Lot Number: RK02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 02/18/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown