MAUDE Adverse Event Report: KARL STORZ SE & CO. KG METAL OUTER SHEATH, INSULATED, 36 CM

Model Number	33300
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	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Information was received that the product will not be returned for evaluation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, "called in to theatre for an instrument issue, was found that a click line outer sheath was not working to specification due to the locking collar not working.Metal piece was found in the patient which came from the end of the outer sheath.Metal piece was not complete.Coordinator informed and surgeon informed, x-ray ordered and performed".
Additional Manufacturer Narrative
Additional information for device return on march 3,2025 reflected in section d9.Device evaluation was completed on septemeber 19,2025 the bayonet lock at the distal end of the instrument was found to be broken, most likely due to mechanical impact.In addition, the item was manufactured in 2006, the advanced age of the instrument likely contributed to material fatigue and reduced mechanical stability, which in combination with external forces, led to the failure of the bayonet lock.The observed damage is therefore attributed to a combination of mechanical overload and natural aging/wear and tear of the material over time.No manufacturing defects were identified the event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: METAL OUTER SHEATH, INSULATED, 36 CM
• Common Device Name: METAL OUTER SHEATH, INSULATED, 36 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 21580066
• Report Number: 9610617-2025-00397
• Device Sequence Number: 18508539
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 04048551002308
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K935071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 33300
• Device Catalogue Number: 33300
• Device Lot Number: DD1376
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown