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

Model Number	26775UE
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2026
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
It was reported that during a laparoscopic surgery, a monopolar spatula was connected to a valleylab ft10 and initially used with a power platform set at 20 w for pure cut and coagulation.As the energy output was considered insufficient to achieve the desired tissue effect, the surgeon requested an increase in power to 30 w.Upon activating the energy using the monopolar pedal, ignition (spark/fire) occurred at the monopolar instrument.The instrument was immediately removed from the patient's cavity and its use was discontinued.A ligasure maryland device was then introduced as a substitute.However, upon activating the energy with the ligasure device inside the patient's cavity, an energy overload occurred in the device, resulting in thermal damage (burns) to the surgical cannula.Following the event, an exploratory inspection of the patient's abdominal cavity was performed using the laparoscope.The inspection revealed: thermal injuries to the patient's abdominal wall, attributed to the energy overload caused by the ligasure device.Presence of melted polymeric debris within the cavity, originating from the compromised cannula structure.Corrective actions / clinical outcome: due to these complications, the failure of the surgical supplies, and in order to ensure patient safety, the surgical team made the clinical decision to convert the laparoscopic procedure to an open surgery.Based on this information the case 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: 24988520
• Report Number: 2020550-2026-00919
• Device Sequence Number: 13381853
• Product Code: GEI
• UDI-Device Identifier: 04048551072394
• UDI-Public: 04048551072394
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 04/24/2026
• Report Date (Section F): 04/24/2026

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: 26775UE
• Device Catalogue Number: 26775UE
• Device Lot Number: YM01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/10/2026
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/24/2026
• 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: Other; Hospitalization; Required Intervention
• Patient Sex: Unknown