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

Model Number	277KB
Medical Device Problem Codes	Electrical Shorting (2926); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that mid case, one of our tur diathermies leads overheated and snapped off at the connection point.No negative impact in state of health reported.
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 the 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
Result of investigation: during inspection of the cable, it was determined that the cable at the instrument connector had suffered damage due to temperature.The cause of the defect is that liquid probably penetrated the cable at the transition point into the instrument plug.At this point, the liquid heated up significantly and exploded.The cause is wear and tear of the product.According to ifu, this could have been detected during a thorough inspection prior to use.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• Common Device Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• 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
• MDR Report Key: 22311697
• Report Number: 9610617-2025-01087
• Device Sequence Number: 8830257
• Product Code: GEI
• UDI-Device Identifier: 04048551090169
• UDI-Public: 04048551090169
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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: 277KB
• Device Catalogue Number: 277KB
• Device Lot Number: SN02
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 10/15/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/18/2025; 10/16/2025
• 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
• Patient Sex: Unknown