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

Model Number	26775UE
Medical Device Problem Codes	Mechanical Problem (1384); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a incomplete shielding were determined burns to the patient's uterus and peritoneum parietal, fortunately without the need for repair surgery.A small solution of continuous of the monopolar spatula stem coating was then detected, which resulted in the aforementioned burns outside the surgical field.
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).
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).
Additional Manufacturer Narrative
Device evaluation: the complained 26775ue was received on august 25,2026 at the manufacturing site and was therefore available for investigation.The investigation has been completed on january 12, 2026.During the manufacturer's technical inspection, the error description provided by the customer "malfunction of 26775ue - sl01" could be confirmed.The most likely root cause: improper handling/ user error the investigation revealed a break in the insulation approximately 15 cm from the distal end of the electrode.This could cause current to leak at this point during use and cause burns to the tissue.The damage to the insulation could have been caused by improper handling (contact with sharp objects during preparation or in the operating room, for example).The instructions for use clearly state that the instrument must be checked for damage; especially to the insulation before each use.The investigation did not reveal any root cause related to the device design, labeling, or manufacturing process.All quality control measures were met, and no non-conformities were found in the production records.The labeling was confirmed to contain adequate instructions and warnings.The event is therefore attributed to a user error.However, we will continue to track and trend complaints according to our procedures.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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja ; 1 s. los carneros road; goleta,, CA 93117
• MDR Report Key: 22890144
• Report Number: 9610617-2025-01469
• Device Sequence Number: 4864407
• Product Code: GEI
• UDI-Device Identifier: 04048551072394
• UDI-Public: 04048551072394
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K944796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2026

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: SL01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 01/12/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/05/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown