MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING ELECTRODE, Ø 3 MM

Model Number	27050N-S
Medical Device Problem Codes	Break (1069); Melted (1385); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bipolar loop melted and broke during a procedure.While in use, the product started to arch, and the connector tip melted and broke.There was no patient injury.The surgeon completed the procedure with minimal delay by replacing the product with a new one.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
The device was returned to our us facility on august 13, 2025.It will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
The device was scrapped in error on (b)(6) 2025.We therefore can no longer ship it to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id: (b)(4).

• Brand Name: COAGULATING ELECTRODE, Ø 3 MM
• Common Device Name: COAGULATING ELECTRODE, Ø 3 MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 22386404
• Report Number: 9610617-2025-01135
• Device Sequence Number: 8680505
• Product Code: FAS
• UDI-Device Identifier: 04048551395431
• UDI-Public: 04048551395431
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K232486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27050N-S
• Device Catalogue Number: 27050N-S
• Device Lot Number: 37GD1832
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 09/17/2025; 06/03/2026
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/15/2025; 09/24/2025; 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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
• Patient Age: 62 YR
• Patient Sex: Male