MAUDE Adverse Event Report: MEDTRONIC XOMED INC. PULSAR I GENERATOR-REFURB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PS100-100RF
Medical Device Problem Codes	Material Separation (1562); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a manufacture representative (rep) regarding a generator and a handpiece.It was reported that during a procedure a piece of the handpiece being used came free of the tip and burned the patient.The burn was full thickness, and the char needed to be excised and three separate areas were stitched as a result of this incident.The sutures needed to be revised and re-stitched.It was also noted that they were unable to use the usb port.5-10 minutes of delay while the wounds were investigated plus additional time to revise.It was stated that there was no impact to the patient outcome.

• Brand Name: PULSAR I GENERATOR-REFURB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 11147989
• Report Number: 1045254-2021-00016
• Device Sequence Number: 896719
• Product Code: GEI
• UDI-Device Identifier: 00643169078406
• UDI-Public: 00643169078406
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PS100-100RF
• Device Catalogue Number: PS100-100RF
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/11/2021
• 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: Required Intervention