MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH, FOR 27040 SD/SL

Model Number	27040XA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, a 75 year old patient was hospitalized for a transurethral bladder resection.During the procedure, the ceramic tip of the inner sheath of the ch26 resectoscope broke off inside the patient's bladder (ref 27040xa/xc26040xa lot if).It was removed without difficulty using the resection loop.No consequences.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
The product has been returned to a third party for repair and is not expected to be returned.Should additional information become available a supplemental will be submitted.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: INNER SHEATH, FOR 27040 SD/SL
• Common Device Name: INNER SHEATH, FOR 27040 SD/SL
• 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: 24573147
• Report Number: 9610617-2026-00535
• Device Sequence Number: 8384257
• Product Code: HIH
• UDI-Device Identifier: 04048551076521
• UDI-Public: 04048551076521
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• 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): 04/03/2026

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: 27040XA
• Device Catalogue Number: 27040XA
• Device Lot Number: IF
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 26040XC INNER SHEATH, FOR 27040 SL; 27040XC
• Patient Sex: Unknown