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

Model Number PS210-030S-SPE

Device Problems Energy Output Problem (1431); No Device Output (1435)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Analysis summary: complaint confirmed: ¿pin 1 to the tip was open.Manipulating the handle helped creating a continuity.Pin 1 to pins 2 and 4 had 0.7 ohm connection when the corresponding button was pressed.This showed there was nothing wrong from pin 1 to the internal board and the disconnection happened at the omega clip.Since there was no video of the sting issue on a good shaped device, the device was activated at coag 10 on 1000 ohm load while recording a video to see how the sting issue happened.The sparks at the shaft create electromagnetic noise that caused the flickering in the video.External melt was happening.There was thermal image of the handle while the spark was happening.Opening the device was similar to all other sting issues.Conclusion: even though the complaint was no activation, this was a sting issue device meaning if they continue using this device, they would have had sting.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 a generator and a handpiece.It was reported that the device would not activate when opened, swapped to another handpiece and issue resolved.Additional information was received from the rep and it was reported that they opened a different handpiece and it worked fine, so they determined it was a defective handpiece and there wasn't a issue with the generator.No reported clinical impact.

• Brand Name: PLASMABLADE 3.0S (SPE)
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11361996
• MDR Text Key: 233116730
• Report Number: 1226420-2021-00046
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PS210-030S-SPE
• Device Catalogue Number: PS210-030S-SPE
• Device Lot Number: 2001196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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