MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) PLASMABLADE X; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PS210-030S-LIGHT
Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
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) via a manufacture representative (rep) regarding a generator and a handpiece.It was reported that during a case, the lighted plasma blade handpiece malfunctioned.It was stated that the handpiece had continuous power when neither the cut nor coag was activated on the handpiece switch.It was also stated that this happened while he was opening up the pocket.The handpiece was discarded by the site.There was no reported impact to patient outcome.

• Brand Name: PLASMABLADE X
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 11194006
• Report Number: 1226420-2021-00019
• Device Sequence Number: 19907114
• Product Code: GEI
• UDI-Device Identifier: 00763000279172
• UDI-Public: 00763000279172
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2021

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: 01/13/2021
• Initial Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1