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

Model Number	26775C
Medical Device Problem Code	Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
The following was reported: "during a laparoscopic cholecystecomy case, the l-hook instrument had an unexpected energy discharge upon coagulation, resulting in a minimal superficial dent/burn to a patient's upper liver bed tissue.The intended target tissue for coagulation was the liver bed wall at the gallbladder dissection site; however, the electrical output appeared not to remain isolated to the intended tissue and instead affected adjacent upper liver tissue.It was additionally noted that the black plastic outer sheath of the l-hook instrument demonstrated evidence of a burnt surface following use.The surgeon completed haemostasis successfully and confirmed that the liver bed was clear of bleeding.The affected upper liver area appeared minimally burnt without significant tissue damage.No significant bleeding or further complication was identified intraoperatively.The procedure was otherwise completed safely, and no patient harm was identified.Patient was recovered safely and subsequently discharged.Due to an unexpected dent / burn to a patient's upper liver bed tissue, the event is deemed reportable.

• 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: 25234200
• Report Number: 2020550-2026-01142
• Device Sequence Number: 10238580
• Product Code: GEI
• UDI-Device Identifier: 04048551072288
• UDI-Public: 04048551072288
• 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): 05/20/2026
• Report Date (Section F): 05/20/2026

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: 26775C
• Device Catalogue Number: 26775C
• Device Lot Number: WQ01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/11/2026
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2026
• 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