FDA Adverse Event Malfunction Summary report: N

PLASMABLADE 3.0S

MDR report key: 10319331 · Received July 24, 2020

Report

Report Number: 1226420-2020-00074
Event Type: Malfunction
Date Received: July 24, 2020
Date of Event: June 29, 2020
Report Date: July 24, 2020
Manufacturer: MEDTRONIC ADVANCED ENERGY, LLC
Product Code: GEI
UDI-DI: 00763000059811
PMA / PMN Number: K093695
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ME, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

COMPLAINT WAS 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 SEATED TOO HIGH ON THE BLADE DEFINED IN 25-1733 WHICH CONTRIBUTED TO THE DEVICE¿S FAILURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT DURING A CASE THE DOCTOR EXPERIENCED AN OUT OF BOX FAILURE. THE TIPOF THE BLADE FELL OUT WHEN THEY WENT TO MAKE THE FIRST CUT. IT WAS NOTED THAT THEIR WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION FROM THE REP REPORTED THE ISSUE OCCURRED DURING A TOTAL HIP PROCEDURE. IT WAS CLARIFIED THAT THE TIP DID NOT FALL OFF BUT THE OUTER COVERING WAS PEELING AWAY. IT WAS UNKNOWN IF ANY FELL OFF. THERE WAS NO IMPACT TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER HANDPIECE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
787856	PLASMABLADE 3.0S	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	GEI	MEDTRONIC ADVANCED ENERGY, LLC	PS210-030S	1912119	00763000059811

Patients

Seq	Age	Sex	Outcome	Treatment
1