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

Model Number	26055EB
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
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 as follows: intraoperatively the surgeon was using a 22fr bipolar working element that had been repaired by a third party.This repair changed the dimensions of the working element which subsequently would not interlock with the inner and outer sheath.Only one of these items was available in the hospital.An alternative size was offered to the surgeon (26fr) however this was not an appropriate size for the patient and the case was aborted.The patient was awoken out of anesthesia and rebooked for a future date.The procedure is resection of polyps.Since the procedure was aborted, the case is deemed as reportable.

• 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: 22610576
• Report Number: 2020550-2025-01282
• Device Sequence Number: 5384876
• Product Code: HIH
• UDI-Device Identifier: 04048551258309
• UDI-Public: 4048551258309
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/25/2025
• Report Date (Section F): 07/25/2025

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: 26055EB
• Device Catalogue Number: 26055EB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2025
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2025
• 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: Other
• Patient Sex: Unknown