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

Model Number	27040DB
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Result of investigation: the electrode clicks correct in place inside several different working elements.Stamped locking geometry is present and correct.Item 27040db will not be returned.According to the customer, the item was functional at the time of use.Since the cutting loops used were returned and no specific defect could be found during inspection, it cannot be ruled out that the cause lies in item 27040db itself - in particular in the area of handling.However, further analysis is not possible as the item is not available for inspection.The returned electrodes are in specification and lock in place with different working elements.The most likely responsible product - the working element has not been returned.Most likely, this working element has a defective electrode lock, as two batches of electrodes failed to lock at the customers working element, which work fine over here with other working elements.According to our data analysis, there are no comparable defects in other items or complaints of this type.Without the article 27040db, the exact root cause cannot be conclusively determined.A possible root cause could be improper preparation of the item, which could have led to a functional impairment.Alternatively, excessive force during use cannot be ruled out.No corrective actions are required, as no critical and/or systematic deviations were identified during the investigation.However, the customer will be reminded and made aware of the right handling.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that the electrode was not fixed to the working element and continued to separate.As a result of inspecting both products, it was determined that the electrode was defective.The symptom of the defect was that there should have been a fixing groove, but the groove was not properly created.There was no direct impact on the patient, but since the surgery was extended by about 40 minutes the event is deemed 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: 22884801
• Report Number: 2020550-2025-00389
• Device Sequence Number: 18406382
• Product Code: FDC
• UDI-Device Identifier: 04048551075500
• UDI-Public: 04048551075500
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• 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): 08/21/2025
• Report Date (Section F): 08/21/2025

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: 27040DB
• Device Catalogue Number: 27040DB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2025
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2025
• 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