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

Model Number	26775UF
Medical Device Problem Codes	Break (1069); Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip broke off during procedure.The diathermy hook was used inside the left pleura and was given back with the missing tip, the surgeon was informed right away.The surgeon checked the cavity and found nothing.Scrub team searched, but nothing was found.An xray was performed and confirmed by the surgeon, showing nothing present inside.However, the broken off tip of the diathermy hook (approximately 5mm in length) was not found and x-rays were taken.
Additional Manufacturer Narrative
The device in question was returned to manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COAGULATING AND DISSECTING ELECTRODE
• Common Device Name: COAGULATING AND DISSECTING ELECTRODE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 22448924
• Report Number: 2020550-2025-01171
• Device Sequence Number: 15597953
• Product Code: GEI
• UDI-Device Identifier: 04048551072417
• UDI-Public: 04048551072417
• 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): 07/08/2025
• Report Date (Section F): 07/08/2025

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: 26775UF
• Device Catalogue Number: 26775UF
• Device Lot Number: RT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/20/2025
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/08/2025
• 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: Required Intervention
• Patient Sex: Unknown