MAUDE Adverse Event Report: AESCULAP AG MONOPOLAR CABLE W/LG.PIN 12FEET; EQUIPMENT

Model Number	GK246
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with gk246 - monopolar cable w/lg.Pin 12feet.During a thoracostomy, the surgical staff heard a "pop" once the monopolar cord was attached.The cord arced and then severed into two.There was no fraying of the cord but there were sparks.The patient was draped and it occurred over the drape; the spark was quickly doused.There was a 10-minute surgical delay due to the reported event.There was no described harm to patient or surgical staff.Additional information was not provided nor available / was not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: we discovered that the end of theinstrument side is broken.However, there are no indication for a manufacturing or a design related failure.In addition we sent the product to the manufacturer.The results as follows: the manufacturing date of the product was 08/2016.The cause of the damage is arcing due to wear-related strand breakage within the cable.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.Conclusion and root cause is most likely wear and tear.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigation results, a capa is not necessary.

• Brand Name: MONOPOLAR CABLE W/LG.PIN 12FEET
• Common Device Name: EQUIPMENT
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11589537
• Report Number: 9610612-2021-00264
• Device Sequence Number: 4108430
• Product Code: FSM
• UDI-Device Identifier: 04038653077618
• UDI-Public: 4038653077618
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GK246
• Device Catalogue Number: GK246
• Device Lot Number: 633-579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 12/09/2022
• 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
• Patient Sex: Unknown