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

Model Number	PS210-030S-LIGHT
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was unavailable from the site.Complaint was not confirmed: upon receiving, eschar buildup was visible, so the device was decontaminated to properly observe and to complete the analysis.It was determined that the coating on the blade was normal wear and tear from using the device during the procedure.The heat shrink on the device was assembled too high defined in 25-1733 which contributed to the device¿s failure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a manufacturing representative (rep) regarding a handpiece.It was reported that the teflon coating came off the handpiece.The handpiece was being used to dissect and coagulate tissue.The case was completed by opening a new handpiece that worked fine.It was noted that the generator was still in use.Additionally, it was the doctor first and only time using it.The rep did not know if the handpiece was bent.The rep noted the doctor only used it to dissect and spot coag.He did not use the pick-ups.There was no visible residue left in the patient.He had been a user for quite a while and only uses wet lap to clean.The staff at the facility has been trained to do that often.They did not report any unusual build up on the device.There was no impact on patient outcome.

• Brand Name: PLASMABLADE X 3.0S LIGHT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• MDR Report Key: 10319196
• Report Number: 1226420-2020-00073
• Device Sequence Number: 3484769
• Product Code: GEI
• UDI-Device Identifier: 00763000279172
• UDI-Public: 00763000279172
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K193529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: PS210-030S-LIGHT
• Device Catalogue Number: PS210-030S-LIGHT
• Device Lot Number: SM2002111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1