MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATING AND DISSECTING ELECTRODE

Model Number	37370DL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The previous reportability decision for this event was reversed based on a retrospective review.The affected device has been requested for investigation by the manufacturer.Device was returned for investigation.Evaluation findings: the insulation is missing from the distal end hook.The hook is bent.The remaining insulation passed the hi-pot test.There are minor dents/scratches on the insulation.The seal is cracked at the proximal end.There is residue on the connector pin.There is temperature damage inside the distal end of the shaft.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy the device 37370dl had broken inside the patient's body.The user had been able to retrieve all pieces that they could find, and no harm occurred to the patient.

• Brand Name: COAGULATING AND DISSECTING ELECTRODE
• Common Device Name: COAGULATING AND DISSECTING ELECTRODE
• 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: christiane klaiber ; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 18004650
• Report Number: 9610617-2023-00323
• Device Sequence Number: 20742657
• Product Code: KNF
• UDI-Device Identifier: 04048551155653
• UDI-Public: 4048551155653
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

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: 37370DL
• Device Catalogue Number: 37370DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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