FDA Adverse Event Malfunction Summary report: N

CUSA EXCEL 36KHZ STRAIGHT HANDPIECE

MDR report key: 3190697 · Received June 24, 2013

Report

Report Number: 3006697299-2013-00054
Event Type: Malfunction
Date Received: June 24, 2013
Date of Event: May 22, 2013
Report Date: June 24, 2013
Manufacturer: INTEGRA LIFESCIENCES IRELAND LIMITED
Product Code: LFL
PMA / PMN Number: K981262
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING USE, THE COOLING ALARM WENT OFF AND THE HANDPIECE BECAME DISABLED TO FUNCTION. THE ISSUE WAS RESOLVED AFTER THE HANDPIECE WAS REPLACED. WHEN THE AMCO ENGINEER (DISTRIBUTOR) TESTED THE DEFECTIVE HANDPIECE IN THEIR OFFICE, SEVERAL AIR BUBBLES WERE FOUND IN THE COOLING CIRCUIT; SUSPECTED TO HAVE A CRACK OR CONNECTION FAILURE INSIDE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE DISTRIBUTOR AND THE FOLLOWING INFORMATION WAS PROVIDED ON (B)(4) 2013: PATIENT AGE AND GENDER WERE UNKNOWN TYPE OF SURGERY WAS A HEPATECTOMY. IT WAS REPORTED THAT RIGHT AFTER THE SETTING WAS FINISHED AND RIGHT BEFORE USING THE HANDPIECE FOR THE SURGERY, THE COOLING ALARM OCCURRED WHEN THE CUSTOMER STEPPED ON THE FOOTSWITCH. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE REPLACEMENT HANDPIECE WAS NOT READILY AVAILABLE BUT THEY REPLACED IT AS SOON AS POSSIBLE. THERE WAS A DELAY IN SURGERY BUT THE PROCEDURE HAD BEEN PERFORMED WITHOUT THE HANDPIECE, SO THE PROBLEM DIDN'T REALLY AFFECT THE PROCEDURE. THE PATIENT WASN'T AFFECTED BY THE PROBLEM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
285471	CUSA EXCEL 36KHZ STRAIGHT HANDPIECE	ULTRASONIC SURGICAL PRODUCTS	LFL	INTEGRA LIFESCIENCES IRELAND LIMITED

Patients

Seq	Age	Sex	Outcome	Treatment
1