FDA Adverse Event Malfunction Summary report: N

MICRO AIRE MICRO DRILL

MDR report key: 8122 · Received April 7, 1994

Report

Report Number
8122
Event Type
Malfunction
Date Received
April 7, 1994
Date of Event
April 4, 1994
Report Date
April 6, 1994
Manufacturer
MICRO-AIRE SURGICAL INSTRUMENTS, INC
Product Code
HBF
Product Problem
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

PT INJURY NOT INVOLVED. WHILE USING THE DRILL TO PLACE CRANIAL PLATES ON BONE FLAP, THE SURGICAL TEAM EXPERIENCED A SUDDEN SEPARATION OF THE DRILL'S MAIN BODY FROM ITS SWIVEL PIECE (THE PART THAT ATTACHES THE DRILL TO THE AIR HOSE), IE, THE ANGLED BASE. DURING THE 15 SECONDS IT TOOK FOR THE CIRCULATING RN TO TURN OFF THE NITROGEN FLOW, THE HOSE AND ATTACHED ANGLED BASE WERE WHIPPING AROUND OUT OF CONTROL (AS THE HOSE WAS STILL UNDER 100 PSI BLOWING OUT OF THE NOW OPEN END.) THE HOSE AND ANGLED BASE CAME VERY CLOSE TO STRIKING THE EXPOSED BRAIN OF THE PT AND MIGHT HAVE IF ONE OF THE DRS HADN'T BEEN ABLE TO COVER THE OPEN BRAIN WITH A FREE HAND.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MICRO AIRE MICRO DRILL MICRO DRILL HBF MICRO-AIRE SURGICAL INSTRUMENTS, INC 1140-200

Patients

Seq Age Sex Outcome Treatment
1 UNK Other