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

Model Number	26055GP1
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Explosion (4006)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/19/2025
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
The following was reported: after two brief activations, the third activation triggered a suspected explosion of the resectoscope loop, resulting in extensive burn marks inside the patient's uterine cavity.Following this malfunction, the surgeon switched to an ibs (intrauterine big shaver) system to complete the treatment, along with a subsequent dilation and curettage.Post-procedure visual inspection revealed complete disappearance of the active loop, disconnection on the return electrode side, and no signs of burning at the teflon block connecting the resectoscope loop to the handpiece.The patient is currently in stable condition and has been discharged.The depth of endometrial damage caused by this incident could not be determined.Due to the injury (extensive burn marks) to the patient's uterine cavity, this case is deemed reportable.

• Brand Name: CUTTING LOOP, BIPOLAR
• Common Device Name: CUTTING LOOP, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 23744788
• Report Number: 2020550-2025-02272
• Device Sequence Number: 8449238
• Product Code: HIN
• UDI-Device Identifier: 04048551393222
• UDI-Public: 04048551393222
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2025
• Report Date (Section F): 12/08/2025

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: 26055GP1
• Device Catalogue Number: 26055GP1
• Device Lot Number: SO02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2025
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2025
• 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: Disability
• Patient Sex: Unknown