MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ELECTRODE, BIPOLAR

Model Number	011050-10
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "hysteroscopic resection of a uterine polyp and fibroid performed on 13/01 in the operating room.A 15ch bipolar resectoscope was correctly assembled (assembly verified).Generator unit in place.Introduction of the resectoscope.Resection of two chips caused sparks, leading to the immediate interruption of the procedure and removal of the resectoscope.Consequences: a new loop from another lot was used, and there were no issues with this new loop.Extension of the operating time by 10 minutes.The patient was doing well in the immediate postoperative period." 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
Result of investigation: as the device in question was not returned by the customer, a physical investigation of the product itself could not be performed.However, the available information has been reviewed.Based on the available information, the experience of the investigator and similar complaints, the most probable root cause is the defect of the camera head cable shielding.This led consequently to disturbance of image during the use of high frequency units and fits to the failure description of customer "monitor intermittently goes blank".The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
This previously submitted supplemental is being redacted.Sup1 was filed inadvertently.The additional information reported in sup1 has been correctly reported in sup 1.

• Brand Name: ELECTRODE, BIPOLAR
• Common Device Name: ELECTRODE, BIPOLAR
• 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: 24264852
• Report Number: 9610617-2026-00211
• Device Sequence Number: 21346938
• Product Code: FAS
• UDI-Device Identifier: 04048551412633
• UDI-Public: 04048551412633
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K221893
• 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): 02/24/2026

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: 011050-10
• Device Catalogue Number: 011050-10
• Device Lot Number: 858264
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/05/2026; 02/20/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/19/2026; 02/24/2026
• 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 Sex: Unknown