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 Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury
Event or Problem Description
On may 25th, 2022 we have been informed about an incident involving a dispersive electrode.A cardiovascular procedure was performed at (b)(6) hospital (b)(6).A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator has been used.The initial user report stated: "historical perspective from surgeon mid april and early may.4 separate patients with wounds after the or.Suspicious for burns.Areas include where the pad was or where the cords were.No similarities in procedures, or staff, generators, surgeons, different lot numbers, etc.No pads were saved for analysis.The surgeon could not speak if a burn specialist has confirmed if this was thermal or chemical related yet." 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.This report is identical to the initial data from our complaint ref: (b)(4), fda medwatch report 3500a 8020045-2022-00016.However, the initial reporter insisted these were different cases and had not been duplicated.On june 15th, we have been informed "the 3rd follow-up was sent on 06/08 (to the complainent) but we didn't receive a response, this file will be closed as no device returned." no conclusion can be drawn what might have caused the incident.We therefore also close the investigation.

• 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: 14752085
• Report Number: 8020045-2022-00017
• Device Sequence Number: 19399073
• 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
• Report Date (Section B): 06/21/2022

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: 05/25/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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