INDIGO?

Report

Report Number: 1045254-2014-00221
Event Type: Injury
Date Received: September 12, 2014
Date of Event: August 7, 2014
Report Date: August 18, 2014
Manufacturer: MEDTRONIC XOMED INC.
Product Code: HBE
PMA / PMN Number: K081475
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS. 1845020 - ATTACHMENT 1845020 INDIGO OTOL ANGLED; SERIAL NUMBER - (B)(4); 1845010 - ATTACHMENT 1845010 INDIGO OTOL STRAIGHT; SERIAL NUMBER - (B)(4). (B)(4). THE PRODUCT ANALYSES INDICATE THAT NO FAULT WAS FOUND WITH THE DRILL AND ATTACHMENTS. THE DRILL WAS EXAMINED BY QES AND TESTED BY TECHNICIANS. IT WAS TESTED WITH THE CUSTOMER¿S STRAIGHT AND ANGLED ATTACHMENTS WITH A TEST BUR. THE DRILL DID NOT OVERHEAT, DID NOT MAKE ANY UNUSUAL SOUNDS DURING TESTING, AND PASSED ALL FUNCTIONAL AND RPM TESTS. THE DRILL TEMPERATURE WAS 73 DEGREES BEFORE STARTING AND 79 DEGREES AFTER 1 MINUTE OF OPERATION. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DRILL HEATED UP WITHIN A FEW SECONDS OF RUNNING, HAD A NOTICEABLE WOBBLE, AND MADE AN ODD NOISE. THE DRILL HEAD AND ATTACHMENT WERE RESEATED; THE DEVICE WAS TRIED AGAIN WITH THE SAME RESULTS. THE CUSTOMER TRIED A THIRD TIME WITH THE SAME RESULT. THEN A NEW ATTACHMENT WAS TRIED AND STILL NO CHANGE. DUE TO THE FAILURE OF THE DRILL, IT WAS NOT USED ON THE PATIENT. HOWEVER, THE PROCEDURE WAS DELAYED AFTER THE PATIENT WAS ANESTHETIZED. EVEN THOUGH THE MEDTRONIC DEVICE WAS NOT PUT INTO USE, THE PATIENT HAD ALREADY RECEIVED ANESTHESIA, WHICH CARRIES INHERENT RISKS, AND REQUIRED ADDITIONAL ANESTHESIA TO COMPLETE THE PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
564195	INDIGO?	DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)	HBE	MEDTRONIC XOMED INC.	1845000	208259368

Patients

Seq	Age	Sex	Outcome	Treatment
1