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

Model Number	26055EB
Medical Device Problem Codes	Fitting Problem (2183); Misassembly During Maintenance/Repair (4054)
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.
Additional Manufacturer Narrative
Result of investigation: the device was not sent to the manufacturer for evaluation.Therefore, no technical inspection by the manufacturer could be performed.The customer reported issue, "no locking with inner/outer jacket," could not be confirmed.The customer confirms that the work element was previously repaired by a third party, which increased its outer diameter and means that it cannot be inserted into the shaft tube.According to the ifu, only karl storz or companies authorized by karl storz are permitted to perform repairs on this device.The event is filed under internal karl storz complaint id: (b)(4).

• 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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 22610579
• Report Number: 9610617-2025-01282
• Device Sequence Number: 14798759
• Product Code: HIH
• UDI-Device Identifier: 04048551258309
• UDI-Public: 4048551258309
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K221893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown