MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR RESECTOSCOPE

Model Number	26050CA
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
The customer did not provide any error description.During initial evaluation of the product (26050ca inner sheath for resectoscope) it was found that there is a loose adhesive bond at the ceramic beak and the beak has come off from the sheath.No negative impact in state of health reported.

• Brand Name: INNER SHEATH FOR RESECTOSCOPE
• Common Device Name: INNER SHEATH FOR RESECTOSCOPE
• 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: 22340759
• Report Number: 9610617-2025-01106
• Device Sequence Number: 15686009
• Product Code: HIH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/25/2026

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: 26050CA
• Device Catalogue Number: 26050CA
• Device Lot Number: OM01
• Date Returned to Manufacturer: 05/30/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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