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

Model Number	011050-10
Medical Device Problem Codes	Break (1069); Explosion (4006)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information received, during a hysteroscopy procedure, a 15 fr bipolar loop ruptured (exploded) during use, making it impossible to continue the surgical procedure.It was stated that the procedure was performed only partially, according to the surgical report and the soot left in the uterus as a result of the loop rupture was aspirated, and corticosteroids plus antibiotics were administered to the patient.It was stated that the patient's hospitalization was not prolonged.
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).

• Brand Name: Electrode, bipolar
• Common Device Name: Electrode, bipolar
• Manufacturer (Section D): KARL STORZ SE & Co. KG; dr.-karl-storz-strasse 34; tuttlingen 78532
• MDR Report Key: 50184707
• Report Number: 50184707
• Device Sequence Number: 10007993
• Product Code: FAS
• UDI-Device Identifier: 04048551412633
• UDI-Public: 04048551412633
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026
• Report Date (Section F): 08/07/2026

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: 848251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/24/2026
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Article: 26053CB.LOT: RK01.; Article: 26053CB.LOT: YN04.; Article: 26053EB.LOT: ZN01.; Article: 26053SC.LOT: ZN02.; Article: 26120AA.Serial: (b)(6).; Article: UH400.Serial: (b)(6).; Article: UH801.LOT: YN03.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown