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 clickline 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".

• 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
• MDR Report Key: 21580067
• Report Number: 2020550-2025-00397
• Device Sequence Number: 9467785
• Product Code: GCJ
• UDI-Device Identifier: 04048551002308
• UDI-Public: 04048551002308
• 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): 03/11/2025
• Report Date (Section F): 03/11/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/19/2025
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2025
• 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