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

Model Number	26775UE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that there was a malfunction of the cauterisation instrument used during laparoscopic surgery (electrified spatula for electrodissection) during an anterior rectal resection.The cause of the malfunction was identified as damage to the instrument's shielding, which caused visceral damage outside the surgical field.This damage was promptly repaired by suturing.A solution of continuous on the coating of the shaft was also found, which caused a burn on the intestine.

• 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: 22199832
• Report Number: 2020550-2025-00992
• Device Sequence Number: 15384163
• Product Code: GEI
• UDI-Device Identifier: 04048551072394
• UDI-Public: 04048551072394
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/12/2025
• Report Date (Section F): 06/06/2025

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: 26775UE
• Device Catalogue Number: 26775UE
• Device Lot Number: TM01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/04/2025
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2025
• 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