MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. MEGADYNE; ELECTROSURGICAL DISPERSIVE ELECTRODE

Model Number	RS271A30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021 we have been informed about an incident involving a dispersive electrode.An aortic valve replacement (avr) and coronary artery bypass grafting (cabg) procedure was performed at adventhealth orlando hospital in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator were used.The initial user report stated: "it was reported by the sales rep that during the cabg and avr procedure, the pad was placed on the patient's lower back and when they removed it, they noticed there was a large red spot there.The patent has been treated." no further information was provided despite repeated requests.
Additional Manufacturer Narrative
As neither a lot number nor samples have been made available to us, no analyses of dispersive electrodes could be performed.We have requested for additional information and the involved device in the incident but have not yet received either.After several requests for further information none has been made available to us.No conclusion can be drawn what might have caused the incident.We will provide a follow-up report once we receive further information.
Additional Manufacturer Narrative
As neither a lot number nor samples have been made available to us, no analyses of dispersive electrodes could be performed.We have requested for additional information and the involved device in the incident but have not yet received either.After several requests for further information none has been made available to us.On june 23th, 2022 we have been informed that "this file has been completed and is in closed status".Requesting additional information, we have been informed on june 24th that "no further information was received".No conclusion can be drawn what might have caused the incident.We therefore consider the investigation closed.
Event or Problem Description
On may 19th, 2022 we have been informed about an incident involving a dispersive electrode.An aortic valve replacement (avr) and coronary artery bypass grafting (cabg) procedure was performed at advent health orlando hospital in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator were used.The initial user report stated: "it was reported by the sales rep that during the cabg and avr procedure, the pad was placed on the patient's lower back and when they removed it, they noticed there was a large red spot there.The patent has been treated." no further information was provided despite repeated requests.

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek road; cincinnati OH 45242
• Manufacturer (Section G): LEONHARD LANG GMBH; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• Manufacturer Contact: bernhard ladner ; archenweg 56; innsbruck, tirol 6020 ; AU 6020
• MDR Report Key: 14692691
• Report Number: 8020045-2022-00013
• Device Sequence Number: 5176023
• Product Code: GEI
• UDI-Device Identifier: 39005531507778
• UDI-Public: (01)39005531507778
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K063161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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?: No
• Device Model Number: RS271A30
• Device Catalogue Number: 0855C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown