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	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.
Additional Manufacturer Narrative
Result of investigation: 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.If the visceral damage had not been detected promptly, serious complications such as perforation or peritonitis could have occurred.In addition, there was a risk of suture dehiscence in an area not affected by disease.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in section d9 to reflect that the product was returned for evaluation.The investigation is not completed yet.The investigation results are pending.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 fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22199914
• Report Number: 9610617-2025-00992
• Device Sequence Number: 7714454
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/10/2025; 08/06/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 07/07/2025; 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Unknown