MAUDE Adverse Event Report: LEONHARD LANG GMBH MEGADYNE; ELECTROSURGICAL DISPERSIVE ELECTRODE

Model Number	RS271A30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/14/2020
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 disperive 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 been informed by the distributor on (b)(6) 2020 that "this file was closed".We expect to receive no further information.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 and the subsequent patient burn at the site of surgery thus 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.
Event or Problem Description
On (b)(6) 2020 we have been informed about an incident involving a dispersive electrode.A right partial mastectomy with lymph node and needle localization procedure was performed at an unknown 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 a right partial mastectomy w[ith] lymph node and needle localization an arching electrical current jumped from the pencil and burned the patient.It is unknown how the case was completed.One device will be returned.".

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 10086457
• Report Number: 8020045-2020-00012
• Device Sequence Number: 19449119
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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
• Operator of Device: Health Professional
• 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: 05/04/2020
• Initial Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other