MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) PLASMABLADE X PS210-030S-LIGHT 3.0SL; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number PS210-030S-LIGHT

Device Problems Energy Output Problem (1431); Failure to Shut Off (2939)

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

Event Date 11/20/2020

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 manufacture representative (rep) regarding a generator and handpieces.It was reported that ta handpiece malfunctioned during a cath lab on the day of the call.Additional information was received from the rep and it was further stated that the hand piece continued to produce power even after surgeon stopped pressing button.A new hand piece was opened and the issue resolved.

• Brand Name: PLASMABLADE X PS210-030S-LIGHT 3.0SL
• 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: 11156189
• MDR Text Key: 226316456
• Report Number: 1226420-2021-00005
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00763000279189
• UDI-Public: 00763000279189
• 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: 01/12/2021

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 Model Number: PS210-030S-LIGHT
• Device Catalogue Number: PS210-030S-LIGHT
• Device Lot Number: 2005069
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: No
• 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