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

Model Number	26040GP1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
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
It was reported that "a hysteroscopic resectoscope and its matching resectoscope loop were used during the procedure.While resecting the intrauterine lesion, the surgeon observed a metallic strip-like object within the uterine cavity under the visual field.Immediate inspection of the resectoscope loop revealed that approximately 5 mm of the front-end metal ring had detached, though the internal wire remained connected.The damaged loop remnant was promptly removed on the operating table.However, during retrieval near the vaginal fornix, the remnant disappeared from the visual field.It was initially suspected that the remnant had been flushed out by the hysteroscopic distension fluid, but repeated examinations of the external fluid collection bucket did not locate the residual fragment.A c-arm was immediately used for fluoroscopic examination, which confirmed that the metallic remnant remained within the patient's vagina.A secondary surgical inspection was immediately performed, and the metallic strip was eventually found on a sterile gauze sponge in the vaginal fornix.After successful retrieval, comparison confirmed that its length and edges matched the damaged section of the resectoscope loop.The surgery proceeded after replacing the resectoscope loop and was completed.Postoperative c-arm fluoroscopy confirmed no residual metallic objects in the patient's body.This incident significantly disrupted the surgical procedure, increased the risk of intraoperative infection and radiation exposure for the patient, and potentially caused mucosal damage to the vagina and uterine cavity during the retrieval process." due to the need for an x-ray to confirm that no parts remained in the body (which required additional medical intervention and extended the procedure), this case is deemed reportable.

• 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, ; GM
• 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: 23438651
• Report Number: 9610617-2025-01961
• Device Sequence Number: 15586858
• 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): 10/31/2025

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: 26040GP1
• Device Catalogue Number: 26040GP1
• Device Lot Number: PL44
• 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: 10/17/2025
• Initial Report FDA Received Date: 10/31/2025
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown