MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING ELECTRODE, L. 36 CM

Model Number	26775B
Medical Device Problem Codes	Material Fragmentation (1261); Overheating of Device (1437); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information received, the electrode broke inside the patient.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 manufacturer on april 22,2025.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 returned electrode was visually inspected and evaluated for signs of damage and wear.Clear evidence suggests that an attempt was made to mechanically alter the shape of the electrode hook, likely using pliers.This is supported by visible indentation marks on the insulation.One area of the insulation showed signs of thermal damage, where the insulation has melted, most likely due to excessive application time during use, resulting in localized heat buildup.The electrode is over 8 years old, and its condition reflects typical signs of aging and wear consistent with prolonged use and reprocessing.The damage to the electrode is most likely the result of user misuse, specifically mechanical manipulation and excessive activation time.Given the product's age and the identified signs of wear, the issue is considered to be use-related and not due to a product defect.No manufacturing defects were identified during the investigation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COAGULATING ELECTRODE, L. 36 CM
• Common Device Name: COAGULATING ELECTRODE, L. 36 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, CA 90245
• MDR Report Key: 21852999
• Report Number: 9610617-2025-00635
• Device Sequence Number: 8607717
• Product Code: GEI
• UDI-Device Identifier: 04048551072264
• UDI-Public: 04048551072264
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2025

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: 26775B
• Device Catalogue Number: 26775B
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 06/11/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/13/2025; 06/30/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown