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

Model Number	26775UE
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	03/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during laparoscopic surgery, a malfunction of the cautery device has been reported, due to an incompleted shielding, which caused damages to the rectum, out from the operative field.In particular, malfunctioning is related to a small breach in the protective coating of the device, located at 10 cm upstream of the distal end.That caused a lateral current discharge during electrical dissection.[this] resulted in damage at rectum level.The patient has been discharged without any permanent damage, as a result of the event.The burn, caused by the device, affected an intestine section, which was removed during surgery.The removal of the affected intestinal part was necessary for the successful outcome of the surgery and was not related directly to the burn.
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).

• 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: 21766673
• Report Number: 2020550-2025-00548
• Device Sequence Number: 15638013
• 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): 04/03/2025
• Report Date (Section F): 04/03/2025

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: SL01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/02/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• 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