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

Model Number	R27050XB
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned to the manufacturing site for investigation.In the event the device returns and relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported during a turp biopsy procedure on (b)(6) 2024, there was a breakage of the ceramic.No negative impact in state of health reported, the doctor was able to remove the broken piece floating around and there was a surgal delay of approximately 25 minutes while attempting to remove the broken pieces.However, it was reported that it's hard to tell if the broken piece may have cut the patient on the way out.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: according to the customer's description, part of the ceramic insert has broken off.One possible cause for this could be, for example, that the ceramic tip was damaged beforehand due to improper handling, or it could be a consequential error due to a burnt-out loop, in which case the thermal effect could also have an impact on the properties of the ceramic.However, as the item is not available for examination, no more precise statement can be made about the fault pattern.This event is filed under internal complaint id (b)(4).

• Brand Name: INNER SHEATH, FOR 27050 SM
• Common Device Name: INNER SHEATH, FOR 27050 SM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21092143
• Report Number: 9610617-2024-00551
• Device Sequence Number: 20998869
• Product Code: FBO
• UDI-Device Identifier: 04048551078167
• UDI-Public: 04048551078167
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K943668
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: R27050XB
• Device Catalogue Number: R27050XB
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 60 YR
• Patient Sex: Unknown