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

Model Number PS210-030S

Device Problem Device Damaged Prior to Use (2284)

Patient Problem Bacterial Infection (1735)

Event Date 11/03/2021

Event Type  Injury  

Event Description

Information was received from a healthcare provider regarding a handpiece.It was reported that the surgeon emailed the following complaint: "our infection rate increased from zero over many years to 40% when we initiated plasmablade x into one of our procedures (abdominoplasty).It's always a methicillin sensitive staph aureus.We have changed nothing else, we irrigate wounds with dilute chlorhexidine gluconate and have sterile air (uv24 system installed), sterile field, and sterile surfaces (fog with halosil system)".No further information reported and no patient involved at this time.

Manufacturer Narrative

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

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12852564
• MDR Text Key: 281088258
• Report Number: 1226420-2021-00138
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS210-030S
• Device Catalogue Number: PS210-030S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• 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
• Patient Outcome(s): Other