FDA Adverse Event Malfunction Summary report: N

DRILL,80K VISAO HANDPIECE 1/EA

MDR report key: 2992127 · Received March 7, 2013

Report

Report Number: 1045254-2013-00224
Event Type: Malfunction
Date Received: March 7, 2013
Date of Event: February 8, 2013
Report Date: February 8, 2013
Manufacturer: MEDTRONIC XOMED INC.
Product Code: ERL
PMA / PMN Number: K011321
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). ANALYSIS: THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. NO SIGNIFICANT CORROSION WAS NOTED ON THE NOSE BEARINGS. NO OTHER PHYSICAL DAMAGES WERE NOTED. THE DRILL WAS CONNECTED TO A TEST IPC AND RUN AT 80 ,000 RPM (MAX SPEED) IN THE FORWARD DIRECTION; MOTOR SOUNDED NORMAL, BUT IT WAS NOTED THAT THE DRILL BEGAN TO WARM AFTER APPROXIMATELY 5 SECONDS. A PRE-TEMPERATURE REPAIR CHECK WAS THEN PERFORMED. THE TEMPERATURES RECORDED: NOSE-160, MIDDLE 175, AND REAR 119. THE MEASURED TEMPERATURES AT NOSE AND MIDDLE LOCATIONS EXCEED SPECIFICATION. EVALUATION CONFIRMED THE REPORTED EVENT; OVERHEATING. THE NOSE AND MIDDLE BEARINGS WERE REPLACED, AND THE FRONT SHAFT SPACER WAS REWORKED DUE TO BEING INSTALLED BACKWARDS. BASED ON ALL THE OBTAINED INFORMATION, THE MOST LIKELY CAUSE OF THE EVENT IS CONSIDERED TO BE WEAR TO THE BEARINGS DUE TO ANTICIPATED USE. THE INCORRECTLY INSTALLED SPACER IS CONSIDERED TO BE A POSSIBLE CONTRIBUTING FACTOR, BUT NOT A PRIMARY CAUSE.

Description of Event or Problem · 1

AS REPORTED THE PRODUCT HEATED UP DURING A CASE, IT GOT HOT ENOUGH THAT THE SURGEON COULD NOT CONTINUE TO HOLD IT. THIS DELAYED THE CASE WHILE THEY SWITCHED IT OUT, NO REPORTED PATIENT IMPACT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
97929	DRILL,80K VISAO HANDPIECE 1/EA	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE	ERL	MEDTRONIC XOMED INC.	3334800	205390915

Patients

Seq	Age	Sex	Outcome	Treatment
1