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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACRA-CUT, INC. DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)

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ACRA-CUT, INC. DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) Back to Search Results
Lot Number 10132
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Laceration(s) (1946)
Event Date 02/28/2022
Event Type  Injury  
Event Description
History of parkinson's disease.To surgery (b)(6) 2022 for bilateral dbs lead placement (dual arrays), electrode 'plcmt,' with mers (first array) - 61867, electrode 'plcmt,' with mers (each additional array) - 61868.During drilling of the burr holes with a perforator drill bit, the drill bit was supposed to stop drilling before it hit/cut the dura, however it didn't stop like it was supposed to and it hit/cut the dura.The surgery was going to have the dura and the brain entered anyway so there was no harm in this case with no additional care.It entered the dura too quickly; wasn't under control.Occurred in benign area of the brain.The surgery team retrieved another perforator drill bit before proceeding with drilling the other burr hole.No harm in this case but per surgeon if this would have occurred in a critical part of the brain it could have been disastrous.Fda safety report id# (b)(4).
 
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Brand Name
DISPOSABLE CRANIAL PERFORATOR WITH HUDSON END 14/11MM
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
Manufacturer (Section D)
ACRA-CUT, INC.
MDR Report Key13691834
MDR Text Key286852337
Report NumberMW5107917
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number10132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/07/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age68 YR
Patient SexMale
Patient EthnicityNon Hispanic
Patient RaceWhite
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