MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR, 26 FR.

Model Number	26040GP1
Medical Device Problem Codes	Fracture (1260); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was admitted with the chief complaint of "prolonged menstrual periods for over 9 years." on november 20, under intravenous combined anesthesia, the patient underwent hysteroscopic resection of a uterine lesion (endometrial polyp resection) + diagnostic dilation and curettage + removal of an intrauterine contraceptive device.After routine draping, the hysteroscope was inserted.While preparing for electrosurgical resection during the procedure, the resectoscope loop suddenly sparked.The hysteroscope was immediately withdrawn for inspection, which revealed a fracture at the connector of the disposable hysteroscopic resectoscope.The procedure continued as planned after replacing the disposable hysteroscopic resectoscope.It was confirmed that the product concerned has been scrapped by the hospital after being damaged and cannot be returned.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been scrapped by the hospital.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: CUTTING LOOP, BIPOLAR, 26 FR.
• Common Device Name: CUTTING LOOP, BIPOLAR, 26 FR.
• 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: 23851366
• Report Number: 9610617-2025-02371
• Device Sequence Number: 13154638
• Product Code: HIN
• UDI-Device Identifier: 04048551392720
• UDI-Public: 04048551392720
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122983
• 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
• Report Date (Section B): 12/19/2025

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: 26040GP1
• Device Catalogue Number: 26040GP1
• Device Lot Number: OK05
• 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: 12/03/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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