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	06/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information received ceramic ring broke off.The shaft broke off while the patient was being operated on.The piece that broke off fell into the patient.It was difficult to find due to clots but was eventually removed from the bladder.The procedure was then stopped, and the sharp shaft was withdrawn.The patient still needs to be reassessed.
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).

• 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: 22322815
• Report Number: 2020550-2025-01090
• Device Sequence Number: 18345938
• Product Code: FJL
• UDI-Device Identifier: 04048551077412
• UDI-Public: 04048551077412
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 06/24/2025
• Report Date (Section F): 06/23/2025

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: ZL05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/05/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• 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