MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT, BIPOLAR

Model Number	26055EB
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested by the manufacturer and has not yet returned for evaluation.The investigation will beperformed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the resectoscope had been used approximately twice when it came apart, giving the impression of a defective weld.The incident was detected during the second use.The customer indicates that the working element enters the patient through the distal tip; however, on the handle side it does not extend into the patient, and this is the area where the component became detached.According to the new information, received on (b)(6) 2026, the healthcare professional reported that during the procedure they gradually noticed that the component was becoming detached.The detachment did not occur suddenly.As a result, the gynecologist was unable to complete the resection, and the component became fully detached when the resectoscope was withdrawn at the end of the procedure.The patient did not experience any adverse effects; however, the myoma could not be completely resected.Therefore, it is likely that the patient will require an additional medical procedure to achieve complete resection of the myoma.

• Brand Name: WORKING ELEMENT, BIPOLAR
• Common Device Name: WORKING ELEMENT, BIPOLAR
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 25895007
• Report Number: 2020550-2026-01692
• Device Sequence Number: 21323978
• Product Code: HIH
• UDI-Device Identifier: 04048551258309
• UDI-Public: 04048551258309
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/21/2026
• Report Date (Section F): 07/21/2026

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: 26055EB
• Device Catalogue Number: 26055EB
• Device Lot Number: NOC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2026
• 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: Other
• Patient Sex: Unknown