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

Model Number	27050XB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknow 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
Correction has been made to sections d1, d2a, d2b and d4 updated the material number from r27050xb to 27050xa.The device in question was returned to the manufacturer on february 7, 2025.This information is reflected in section d9.Should 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).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: the customer's description can be confirmed; a part of the ceramic insert has broken off.As there are traces of smoke on the inside of the ceramic, it can be assumed that the loop burned through during use.The ceramic may have been damaged by the resulting heat.In addition, corresponding signs of use can be seen on the surface of the shaft.As dents can be seen on the surface, it cannot be ruled out that the ceramic may have already been damaged by careless handling, e.G.During reprocessing.It can therefore be assumed that the user is at fault.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: 21092140
• Report Number: 9610617-2024-00549
• Device Sequence Number: 15619398
• Product Code: FJL
• UDI-Device Identifier: 04048551078167
• UDI-Public: 04048551078167
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K221893
• 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,Followup
• Report Date (Section B): 05/20/2025

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: 27050XB
• Device Catalogue Number: 27050XB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/07/2025; 05/07/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/12/2025; 05/20/2025
• 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