FDA Adverse Event Malfunction Summary report: N

TXI TISSUE REMOVAL SYSTEM - CONSOLE

MDR report key: 3902864 · Received February 24, 2014

Report

Report Number: 2085033-2014-00519
Event Type: Malfunction
Date Received: February 24, 2014
Report Date: February 14, 2014
Manufacturer: TENEX HEALTH
Product Code: LFL
PMA / PMN Number: K123640
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ON (B)(4) 2014 UNIT WAS RECEIVED FROM THE FIELD FOR EVALUATION. (B)(4) UNIT FUNCTIONS WITHIN ALL SPECS. COULD NOT DUPLICATE ANY MALFUNCTION. RETEST AND RETURN TO CUSTOMER. ON (B)(4) 2014, THE DHR CONSOLE (B)(4) WAS REVIEWED AND SHOWED THAT THE UNIT MET MANUFACTURING SPECIFICATIONS WHEN RELEASED AND THERE WERE NO ISSUES RELATED TO THE COMPLAINT. A REVIEW OF CONSOLE HISTORY (B)(4) WAS REVIEWED DURING THE MONTHS OF (B)(4) 2013 THROUGH (B)(4) 2014 AND SHOWED THAT THERE WERE NO REPORTED MICROTIP UNIT FAILURES ORIGINATING FROM THIS CONSOLE. UPON FURTHER REVIEW, THIS WAS THE ONLY TIME THIS CONSOLE WAS EVALUATED AND SERVICED DURING THIS TIME PERIOD. THIS CONSOLE WAS NOT AT A FACILITY. THE CONSOLE IS USED BY A SALES REP. FACILITY TRENDING WAS NOT PERFORMED. THE COMPLAINT WAS NOT CONFIRMED. PER THE COMPLAINT UNIT INVESTIGATOR, A CASE OF THIS ISSUE COULD BE THAT THERE MAY NOT BE ENOUGH SALINE BEING USED. THIS WOULD CAUSE THE CONSOLE TO NOT FULLY PRIME. THIS CAUSE CANNOT BE VERIFIED WITH THIS SPECIFIC COMPLAINT. THIS CONSOLE WILL BE MONITORED FOR ANY FURTHER RELATED COMPLAINTS.

Description of Event or Problem · 1

FOR SEVERAL MONTHS NOW I NEED TO OVERRIDE THE CONSOLE AND PUSH SALINE THROUGH THE HANDPIECE'S WITH THE PEDAL. IT HAS HAPPENED NUMEROUS TIMES AND IS A CONCERN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
113594	TXI TISSUE REMOVAL SYSTEM - CONSOLE	ULTRASONIC SURGICAL ASPIRATOR	LFL	TENEX HEALTH

Patients

Seq	Age	Sex	Outcome	Treatment
1