MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC PLASMABLADE X 3.0S LIGHT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PS210-030S-LIGHT
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
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) regarding a generator and handpiece being used for a breast reconstruction surgery.It was reported that the surgeon's arm leaned up against the handpiece while it was not in active use and it burnt their arm.The hcp had set the handpiece down on the patients stomach area and then they leaned too close to the blade it burned their forearm.The device buttons were not activated when the event occurred.It was noted that the hcp had touched the blade 3 to 4 seconds after using it.The burn resulted in a small blister, but did not require treatment.The hcp had to break scrub to clean it and re-scrub in to finish the case.The hcp felt the blade should not have still been hot since the last use of it.There was no damage to the handpiece and it was noted that the smoke evacuation tubing was in place before and after the event.The handpiece was used for the remainder of the case with no further issues.There was a less than hour surgical delay and no impact on patient outcome.

• Brand Name: PLASMABLADE X 3.0S LIGHT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• MDR Report Key: 10565477
• Report Number: 1226420-2020-00114
• Device Sequence Number: 19570380
• Product Code: GEI
• UDI-Device Identifier: 00763000279172
• UDI-Public: 00763000279172
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K193529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: PS210-030S-LIGHT
• Device Catalogue Number: PS210-030S-LIGHT
• Device Lot Number: SM2003049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1