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
Retained samples of the concerned lot number were inspected visually, electrically and mechanically.All electrodes were within limits, no failure could be detected.The involved device has not been made availble for a further investigation.We have requested several times for additional information but have not received any.We have been informed on may 19th, 2020 that "the 2nd attempt to receive answers to your questions was sent 04/28, no further information was provided yet.".We will provide a follow-up report once further information has been available to us.
Event or Problem Description
On (b)(6) 2020 we have been informed about an incident involving a dispersive electrode.A laparoscopic lysis of adhesions 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 by the rep [representative] post operative a laparoscopic lysis of adhesions that was converted to an open incarcerated ventral hernia.The patient experienced skin irritation.Unknown how the irritation was addressed.The device will be returned.".
Additional Manufacturer Narrative
Retained samples of the concerned lot number were inspected visually, electrically and mechanically.All electrodes were within limits, no failure could be detected.The involved device has not been made available for a further investigation.We have requested several times for additional information but have not received any.We have been informed on june 15th, 2020 that the device involved in the incident has been lost because it had been shipped to an outdated address of our distributor.As neither any further information nor the device involved have been made available we close the investigation.No conclusion can be drawn what might have caused the customer problem.
Event or Problem Description
On (b)(6) 2020 we have been informed about an incident involving a dispersive electrode.A laparoscopic lysis of adhesions 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 by the rep [representative] post operative a laparoscopic lysis of adhesions that was converted to an open incarcerated ventral hernia.The patient experienced skin irritation.Unknown how the irritation was addressed.The 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: 10069466
• Report Number: 8020045-2020-00011
• Device Sequence Number: 14110506
• 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,Followup
• Report Date (Section B): 06/15/2020

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 Expiration Date: 02/08/2021
• Device Model Number: RS271A30
• Device Catalogue Number: 0855C
• Device Lot Number: 180208-2404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 06/15/2020
• 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