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 Tears (2516)
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.We have been informed by the customer that "the questionnaire was sent and requested to be completed, but it has not been returned.According to our procedures, 3 attempts are made to gain additional information.No more attempts are made after the 3 attempts are completed whether there is any response or not." based on the information available and the involved electrode not having been made available no further investigations can be performed.No conclusion can be drawn as to what might have caused the patient injury, we therefore close the investigation.
Event or Problem Description
On april 15th, 2019 an ent [ear nose throat] procedure was performed at an unknown hospital.A monitoring dispersive electrode (model rs271a30) and an unknown generator were used.The initial reporter stated: "it was reported by the sales rep that during an ent procedure, it was a bovie pad [dispersive electrode] 0855c, according to the nurse, when they removed the pad, part of the skin came off of the patient, and they did not notice until the end of the procedure when they were removing the pad." requesting additional information we received the information that "i do not know how the patient is doing.After the incident, surgeon ordered bacitracin ointment to the site.No further information known.".

• Brand Name: MEGADYNE
• Common Device Name: ELECTROSURGICAL DISPERSIVE ELECTRODE
• Manufacturer (Section D): LEONHARD LANG GMBH; archenweg 56; innsbruck, 6020 ; AU 6020
• MDR Report Key: 8611683
• Report Number: 8020045-2019-00008
• Device Sequence Number: 13958542
• Product Code: GEI
• UDI-Device Identifier: 19005531507774
• UDI-Public: (01)19005531507774
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/15/2019

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: 08/10/2021
• Device Model Number: RS271A30
• Device Catalogue Number: 0855C
• Device Lot Number: 180810-2405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/15/2019
• 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