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

Model Number PS210-030S-LIGHT

Device Problem Failure to Shut Off (2939)

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

Event Date 06/03/2022

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 manufacturer representative regarding a generator and a handpiece.It was reported that when letting off of the coag button the handpiece was still active.That has happened multiple times.The handpiece was discarded.There was no patient involved.

• Brand Name: PLASMABLADE X
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14633179
• MDR Text Key: 294398018
• Report Number: 1226420-2022-00020
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00763000279165
• UDI-Public: 00763000279165
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/08/2022

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 Model Number: PS210-030S-LIGHT
• Device Catalogue Number: PS210-030S-LIGHT
• Device Lot Number: 2104226
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/26/2021
• 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