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

Model Number	R27050CA
Medical Device Problem Codes	Break (1069); Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to our us facility on february 18, 2025.It will be forwarded to the manufacturing site for investigation.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).
Event or Problem Description
It was reported on (b)(6) 2025, during a turb procedure, the ceramic beak of sheath broke off of instrument inside the patient and needed to be retrieved with other available instrumentation.No information about patient injury and no negative impact in state of health reported.
Additional Manufacturer Narrative
Per investigation by the manufacturing site: after careful analysis of the available information and considering the instructions for use, it can be assumed that the breakage of the ceramic tip during the surgical procedure was 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.Inadequate visual inspection prior to use and possible pre-existing damage from previous cycles may have further contributed to the damage.Overall, everything indicates that a combination of mechanical stress, possible thermal influences, and inadequate inspection prior to the procedure led to the failure of the ceramic tip.This event is filed under internal 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, 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 92344 ; 4242188247
• MDR Report Key: 21433593
• Report Number: 9610617-2025-00276
• Device Sequence Number: 4337276
• Product Code: FBO
• UDI-Device Identifier: 04048551077412
• UDI-Public: 04048551077412
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/15/2025

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: R27050CA
• Device Catalogue Number: R27050CA
• Device Lot Number: ZM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown