MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR HIGH FREQUENCY CORD, 300 CM

Model Number	26176LV
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device 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).Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).
Event or Problem Description
The forcep sparking and smoking.Insulation has separated from the collar where it goes into the handle on all items.Grasper wasn't closing all the way, and the smoking seems to be coming from the distal portion of the insert at the actual grasping mechanism.No negative impact in state of health reported.Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).Cross reference internal complaint id (b)(4).
Additional Manufacturer Narrative
According to the new information there were no indications (on the complaints listed below) that they were used or had anything wrong.Customer simply returned them because they did not like them.This event is filed under internal complaint id (b)(4).Cross reference interal complaint id (b)(4).

• Brand Name: BIPOLAR HIGH FREQUENCY CORD, 300 CM
• Common Device Name: BIPOLAR HIGH FREQUENCY CORD, 300 CM
• 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: 24345335
• Report Number: 9610617-2026-00303
• Device Sequence Number: 18522438
• Product Code: GEI
• UDI-Device Identifier: 04048551100363
• UDI-Public: 04048551100363
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: GEI
• 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
• Report Date (Section B): 02/20/2026

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: 26176LV
• Device Catalogue Number: 26176LV
• Device Lot Number: OL01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown