MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) PLASMABLADE 3.0S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number PS210-030S

Device Problems No Device Output (1435); Device Damaged Prior to Use (2284)

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

Event Date 07/27/2021

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 two handpieces.It was reported that when they we went to use a handpiece and when was taking it out of its box, they found it wasn¿t sealed so they opened a second one to also find that one was also not sealed, therefore both products were not sterile.There was no patient involved.

• Brand Name: PLASMABLADE 3.0S
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12252583
• MDR Text Key: 264331202
• Report Number: 1226420-2021-00116
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00643169617148
• UDI-Public: 00643169617148
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K093695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2022
• Device Model Number: PS210-030S
• Device Catalogue Number: PS210-030S
• Device Lot Number: 0218773538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2019
• 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