FDA Adverse Event Malfunction Summary report: N

VISAO®

MDR report key: 4102133 · Received September 19, 2014

Report

Report Number: 1045254-2014-00226
Event Type: Malfunction
Date Received: September 19, 2014
Date of Event: August 21, 2014
Report Date: August 27, 2014
Manufacturer: MEDTRONIC XOMED INC.
Product Code: ERL
PMA / PMN Number: K011321
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS. XOM UNKNOWN BLADE; MANUFACTURE DATE ¿ UNKNOWN; LOT ¿ UNKNOWN; USE BY DATE ¿ UNKNOWN. (B)(4). THE PRODUCT ANALYSIS INDICATES THAT THE DEVICE OVERHEATED DURING THE ONE MINUTE PRE-TEST (296 DEGREES F - NOSE; 241 DEGREES F - MIDDLE; 83 DEGREES F - REAR). THE NOSE CONE AND NOSE BEARINGS WERE BURNT DUE TO RUNNING THE DRILL WITH SEVERELY CORRODED PARTS. THE MOTOR/CABLE SUBASSEMBLY, BEARINGS, NOSE CONE, AND OTHER PARTS WERE REPLACED. THE DEVICE WAS REPAIRED, CLEANED, TESTED, AND PASSED ALL MANUFACTURING SPECIFICATIONS. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A CASE, THE BUR GOT HOT AND DISCOLORED (TIP OF DRILL AND BUR ARE BLACK) FROM THE HEAT AFTER APPROXIMATELY 15 MINUTES OF DRILLING. THE DOCTOR THOUGHT THE BONE WAS EXTRA HARD UNTIL HE SWITCHED OUT DRILLS AND WAS ABLE TO SUCCESSFULLY COMPLETE THE CASE. THERE WAS NO IMPACT TO THE PATIENT. THE CUSTOMER DISCOVERED RUST IN THE DISTAL TIP OF THE LOCKING MECHANISM AND ATTRIBUTES THE OVERHEATING TO THE HANDPIECE, NOT THE BUR. THE CUSTOMER BELIEVES THAT THE DRILL HAD BEEN COMPROMISED AT SOME POINT DURING ITS PROCESSING IN THEIR CENTRAL PROCESSING DEPARTMENT. THERE WAS NO REPORTED INJURY AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
583845	VISAO®	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE	ERL	MEDTRONIC XOMED INC.	3334800	39753300

Patients

Seq	Age	Sex	Outcome	Treatment
1