MAUDE Adverse Event Report: KARL STORZ SE & Co. KG Electrode, bipolar

Model Number	011050-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that three resection loops broke during the hysteroscopy during normal use.There was a risk of a foreign body remaining in the uterus, requiring irrigation and retrieval procedures.A new sterile package had to be opened to use another loop and recover the broken fragment.The procedure duration and the patient's general anesthesia time were significantly prolonged.The prolongation is unknown.No negative impact in state of health reported.Version bb.Mdr dq: following consultation with medical & scientific affairs, the measures undertaken to remove the foreign body are considered a surgical intervention to prevent permanent impairment or irreversible damage if left untreated.Even so it cannot be conclusively determined whether the foreign body would have resulted in permanent impairment or irreversible damage if left untreated.
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).

• 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
• MDR Report Key: 50040126
• Report Number: 2020550-2026-01729
• Device Sequence Number: 13209813
• Product Code: FAS
• UDI-Device Identifier: 04048551412633
• UDI-Public: 04048551412633
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2026
• Report Date (Section F): 07/27/2026

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: 011050-10
• Device Catalogue Number: 011050-10
• Device Lot Number: 85919H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown