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

Model Number	27050CA
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: the investigation of the product was completed on august 26, 2025.After careful analysis of the available information and taking into account the instructions for use, it can be concluded that the breakage of the ceramic tip during the surgical procedure is due to a multifactorial process.The most likely cause is an application error in which the tip was mechanically overloaded.In addition, thermal influences such as insufficient distance between the electrode and the ceramic insert may have weakened the material.The instructions for use expressly point out that ceramic is a brittle material that is sensitive to mechanical and thermal stress.Even the smallest, initially invisible microcracks can grow through repeated stress (e.G., cleaning, sterilization) and eventually lead to breakage.An insufficient visual inspection before use and possible pre-existing damage from previous cycles may have contributed to the damage.Overall, everything indicates that mechanical stress and insufficient inspection prior to the procedure led to the failure of the ceramic tip.The initial manufacturer mdr was submitted on may 7, 2025.However, due to an oversight, the corresponding importer mdr was not submitted at that time.This was the result of human error, and we sincerely apologize for the delay and any inconvenience it may have caused.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, during a procedure the ceramic tip broke whilst in a patient.The bladder was punctured.All parts of tip recovered.No death or (unanticipated) serious deterioration in state of health reported.

• 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: 22919821
• Report Number: 2020550-2025-00799
• Device Sequence Number: 16010262
• 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): 08/28/2025
• Report Date (Section F): 05/07/2025

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: WO11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/16/2025
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2025
• 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
• Date Report Sent to FDA: 05/07/2025