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	Electric Shock (2554)
Type of Reportable Event	Serious Injury
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 several times for additional information and the device involved in the incident but have not received either.We have repeatedly requested clarification from the initial reporter and the device involved but as of today not received any.Based on the information provided so far, an investigation is impossible.We will continue to request for further information and provide a follow up report once we will receive it.
Event or Problem Description
On (b)(6) 2021 we have been informed about an incident involving a dispersive electrode.An unknown procedure was performed at university of louisville hospital in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator were used.The user report stated: "it was reported by the sales rep [representative] that during an unknown procedure, surgeon was shocked by electric current when using bovie and pick ups during case." no further information was provided despite repeated requests.
Event or Problem Description
On (b)(6), 2021 we have been informed about an incident involving a dispersive electrode.An unknown procedure was performed at university of (b)(6) hospital in the us.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator were used.The user report stated: "it was reported by the sales rep [representative] that during an unknown procedure, surgeon was shocked by electric current when using bovie and pick ups during case." 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 several times for additional information and the involved device in the incident but have not received either.Despite repeated requests no further information has been made available.Our distributor informed us that "this file has been completed and is in closed status." in any case, the incident described occurred not at the site of the dispersive electrode but at the active electrode's / the pencil's.The root cause for the arcing observed at the pencil needs to be searched for at the pencil and the active electrode.We therefore consider the investigation closed and no further conclusion can be drawn.

• 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: 13041992
• Report Number: 8020045-2021-00025
• Device Sequence Number: 17498721
• 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): 01/13/2022

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: 11/29/2021
• Supplement Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 01/13/2022
• 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