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

Model Number	26050CA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Urethral Stenosis/Stricture (4501); Insufficient Information (4580)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
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 at the end of the procedure, the surgeon observed that the ceramic tip of the inner sheath of the resectoscope had detached and was located in the bladder.Due to significant urethral stenosis, extraction via the natural route proved impossible.An attempt was made to fragment it using a 30w holmium laser, allowing partial extraction of a fragment; however, a residual fragment remained in place, inaccessible via the transurethral route.Additionally, perforation of the urethral wall by the ceramic tip led to significant extravasation of saline into the retroperitoneum, evidenced by a discrepancy between the irrigated volume and the aspirated volume.Given the impossibility of extracting the remaining fragment endoscopically, the decision was made to convert to laparoscopy.However, extraction proved particularly difficult due to the retrovesical location of the fragment.The patient had to be transferred to intensive care after extraction of the remaining fragment.

• 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
• MDR Report Key: 25782708
• Report Number: 2020550-2026-01593
• Device Sequence Number: 18548216
• Product Code: HIH
• UDI-Device Identifier: 04048551007228
• UDI-Public: 04048551007228
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2026
• Report Date (Section F): 07/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26050CA
• Device Catalogue Number: 26050CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/25/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Sex: Unknown