MAUDE Adverse Event Report: KARL STORZ SE & Co. KG Coagulating Electrode, l. 43 cm

Model Number	26775C
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: additional information is provided in section d4 and d10 to reflect information received to reflect correct serial number and concomitant device.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 Electrode, l. 43 cm
• Common Device Name: Coagulating Electrode, l. 43 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: theresa mussaw ; 2151 e grand ave; el segundo, CA 90245 ; +1(410)441-1327
• MDR Report Key: 50876097
• Report Number: 9610617-2026-02228
• Device Sequence Number: 9425660
• Product Code: GEI
• UDI-Device Identifier: 04048551072288
• UDI-Public: 04048551072288
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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: 26775C
• Device Catalogue Number: 26775C
• Device Lot Number: SK01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 09/29/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 26006M - Unipolar HIgh Frequency Cord 300 cm; 26006M - Unipolar High Frequency Cord 300 cm
• Patient Sex: Unknown