FDA Adverse Event Malfunction Summary report: N

IPC® HANDPIECE - INDIGO¿ DRILL

MDR report key: 7310883 · Received March 2, 2018

Report

Report Number: 1045254-2018-00080
Event Type: Malfunction
Date Received: March 2, 2018
Date of Event: February 7, 2018
Report Date: April 2, 2018
Manufacturer: MEDTRONIC XOMED, INC.
Product Code: HBE
UDI-DI: 00613994933713
PMA / PMN Number: K081475
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NL
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT DEVICE: INDIGO ATTACHMENT 1845020 , S/N: (B)(4) , LOT NO: 207410087, MANUFACTURING DATE 2013-09-11. 510K: K081475. THE PRODUCTS HAVE BEEN RETURNED. ANALYSIS OF THE DEVICES IS PENDING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

ANALYSIS OF THE DEVICES HAS BEEN COMPLETED. DRILL 1845000 INDIGO HIGH SPEED SERIAL NUMBER (B)(4): COMPLAINT HAS NOT BEEN CONFIRMED. TEMPERATURE TEST AT ONE MINUTE: T1 ¿ 79; T2 ¿ 80. THE DEVICE HAS BEEN SUCCESSFULLY TESTED. CONCOMITANT: INDIGO ATTACHMENT ANGLED 1845020 , S/N: (B)(4) , LOT NO: 207410087: CUSTOMER COMPLAINT CANNOT BE CONFIRMED, TEMPERATURE AFTER 5 MINUTES: 103 F. THIS IS WITHIN OUR SPECIFICATIONS. THE 1845020 DEVICE HAS BEEN SUCCESSFULLY TESTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE DEVICE GETS HOT REALLY QUICKLY DURING USE (IN A FEW SECONDS) AND REGARDING THE ATTACHMENT THAT THEY WERE NOT SURE WHETHER IT'S BECAUSE DRILL GETS HOT, OR BECAUSE THERE'S SOMETHING WRONG WITH THE BEARINGS. THERE WAS NO USER/PATIENT IMPACT OR INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
154136	IPC® HANDPIECE - INDIGO¿ DRILL	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)	HBE	MEDTRONIC XOMED, INC.	1845000	NI	00613994933713

Patients

Seq	Age	Sex	Outcome	Treatment
1