MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC PLASMABLADE 3.0S; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number PS210-030S

Device Problems Fire (1245); Energy Output Problem (1431); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

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) regarding a generator and a handpiece.It was reported that during a clinical case the handpiece was sparking and making a buzzing noise when set to cut level 6.When the setting was put lower than 6, it would not cut properly.He stated that they were using a loaner generator and did not have another to swap to.He was going to swap to a different handpiece and try that.Call disconnected before any other information could be provided on handpiece, generator, site, or caller identification.No further information was available.There was no delay to the procedure.There was no reported impact to patient outcome.

• Brand Name: PLASMABLADE 3.0S
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9267731
• MDR Text Key: 164657299
• Report Number: 1226420-2019-00170
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K093695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 11/01/2019

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
• Device Catalogue Number: PS210-030S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/01/2019
• 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