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

Model Number PS210-030S-LIGHT

Device Problem Failure to Shut Off (2939)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• Manufacturer Contact: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 11194006
• MDR Text Key: 227583729
• Report Number: 1226420-2021-00019
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00763000279172
• UDI-Public: 00763000279172
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1