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

Model Number	26053CB
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the information received, the customer uses 15 fr.Bipolar resectoscope set with autocon iii during operative hysteroscopy.The inner sheath of the resectoscope and the bipolar cutting electrode were broken.All pieces were successfully retrieved during the same surgery with hysteroscopy.No additional intervention was required to retrieve the parts.No death or (unanticipated) serious deterioration in state of health reported.Cross reference mdr 9610617-2026-00554.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.Cross reference complaint id: (b)(4).The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.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, 15 FR.
• 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: 24587964
• Report Number: 9610617-2026-00555
• Device Sequence Number: 12184559
• Product Code: HIH
• UDI-Device Identifier: 04048551410479
• UDI-Public: 04048551410479
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 26053CB
• Device Catalogue Number: 26053CB
• Device Lot Number: SK06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/26/2026
• 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