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

Model Number	011160-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
According to the information received, during an operative hysteroscopy, the gynaecologist observed, upon first use of a single-use bipolar resection loop, the intrauterine projection of an unusual fragment that appeared to be a piece of metal.The procedure was temporarily halted.The fragment was retrieved.The integrity of the resection loop was checked (intact).The origin of the fragment was tested with a magnet: it was found to be "non-metallic," but still considered suspicious by the surgeon.The procedure was halted to investigate the origin of the foreign element.This led to a prolongation of surgical time.A new resection loop had to be used.No death or (unanticipated) serious deterioration in state of health reported.
Additional Manufacturer Narrative
Additional information: 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.The investigation was completed on sep 23, 2025.The device product history records (dhr) have been checked for the available batch number and found to be according to the specification, valid at the time of production.The customer description "the integrity of the resection loop was checked (intact)." leads to the conclusion, the foreign object in question may be from another instrument used during the procedure.Based on the available information, it is concluded that there is no failure on the electrode.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Device evaluation: the findings outlined in the final report without the product have been confirmed during the product investigation after product return.The electrode provided is used, but complete and it can be excluded that the also provided particles are from the electrode.Therefore, it is concluded that there is no failure on the electrode.This event is filed under internal complaint id (b)(4).

• 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: 22359673
• Report Number: 9610617-2025-01121
• Device Sequence Number: 8621312
• Product Code: HIH
• UDI-Device Identifier: 04048438005408
• UDI-Public: 04048438005408
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/28/2025

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: 011160-10
• Device Catalogue Number: 011160-10
• Device Lot Number: 852459
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 11/10/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 09/29/2025; 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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