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	Skin Irritation (2076)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As neither a lot number nor samples have been made available to us, no analyses could be performed so far.We have requested several times for additional information and the device involved in the incident but have not received either.We have been informed on may 19th, 2020 by the distributor that they did not receive any answers from the user facility.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 colostomy reversal surgical procedure was performed at an unknown hospital.A megadyne dispersive electrode catalog number 0855c (our model rs271a30) and an unknown generator were used.The user report stated: "it was reported (.) after a colostomy reversal the patient experienced skin irritation after the pad [dispersive electrode] was removed.It is unknown how the condition was addressed (.).".

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 10069455
• Report Number: 8020045-2020-00009
• Device Sequence Number: 2628594
• 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): 05/19/2020

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: 04/24/2020
• Initial Report FDA Received Date: 05/19/2020
• 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