MAUDE Adverse Event Report: KARL STORZ SE & CO. KG INNER SHEATH FOR 27050 SC

Model Number	27050CA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
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, the instrument was being used with the relative kit to perform a turp.During the resection the surgeon noticed the insulated tip had sheared off the instrument and was floating free in the patient's bladder.The surgeon eventually manage to retrieve the broken part.The patient's procedure could not be carried out as planned; necessary blood loss and procedure took longer than planned.The surgeon suffered the stress of trying to extract the broken part safely without causing further trauma to the patient's bladder.The anaesthetist was concerned because the patient had been given a spinal anaesthetic and the time for its effectiveness was running out.

• Brand Name: INNER SHEATH FOR 27050 SC
• Common Device Name: INNER SHEATH FOR 27050 SC
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 23618839
• Report Number: 2020550-2025-02135
• Device Sequence Number: 9997638
• Product Code: FJL
• UDI-Device Identifier: 04048551077412
• UDI-Public: 04048551077412
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/21/2025
• Report Date (Section F): 11/21/2025

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: 27050CA
• Device Catalogue Number: 27050CA
• Device Lot Number: TN02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/07/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• 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: Other
• Patient Sex: Unknown