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

Model Number RS271A30

Device Problem Insufficient Information (3190)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

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 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.".

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informed on june 15th, 2020 that the device involved in the incident has been lost because it had been shipped to an outdated address of our distributor.As neither any further information nor the device involved have been made available we close the investigation.No conclusion can be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 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
• Type of Device: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 10069466
• MDR Text Key: 191457743
• Report Number: 8020045-2020-00011
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 39005531507778
• UDI-Public: (01)39005531507778
• Combination Product (y/n): N
• PMA/PMN Number: K063161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other