MAUDE Adverse Event Report: AESCULAP AG BIPOLAR COAGULATION UNIT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	GN060
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
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 to aesculap ag that a bipolar coagulation unit (part # gn060) was used during a procedure performed on (b)(6) 2020.According to the complainant, the device power supply failed during the surgical procedure.No known patient complications were reported as a result of the event.Additional information has been requested, but has not yet been received.The malfunction is filed under aag reference (b)(4).
Event or Problem Description
The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: visual investigation: no malfunctions were found during a visual inspection and the electrotechnical examination.The unit works according to the specifications.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.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 investigations results a capa is not necessary.

• Brand Name: BIPOLAR COAGULATION UNIT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10906735
• Report Number: 9610612-2020-00851
• Device Sequence Number: 2895584
• Product Code: GEI
• UDI-Device Identifier: 04038653078035
• UDI-Public: 4038653078035
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: GN060
• Device Catalogue Number: GN060
• Device Lot Number: 51643942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1