MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING AND DISSECTING ELECTRODE

Model Number	26775UF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been returned for evaluation by the manufacturer.The investigation is not completed yet.The investigation results are pending.Internal karl storz reference number: (b)(4).
Event or Problem Description
It was reported that damage rubber of distal tip laparoscopy dissecting electrode and this piece was probably left inside patient.New tool was deliver to continue operation.X-ray were taken but the broken piece was not found.Due to the pot.Fragment in situ the event is reportable.

• Brand Name: COAGULATING AND DISSECTING ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 20034811
• Report Number: 2020550-2024-00294
• Device Sequence Number: 6573929
• Product Code: GEI
• UDI-Device Identifier: 04048551072417
• UDI-Public: 04048551072417
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 08/21/2024
• Report Date (Section F): 08/21/2024

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: 26775UF
• Device Catalogue Number: 26775UF
• Device Lot Number: ZO01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2024
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• 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