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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROMAR INDÚSTRIA E COMÉRCIO LTDA EASYDRILL CRANIAL PERFORATOR 14 X 11 X 3MM; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)

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MICROMAR INDÚSTRIA E COMÉRCIO LTDA EASYDRILL CRANIAL PERFORATOR 14 X 11 X 3MM; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED) Back to Search Results
Model Number DM0010FAA
Device Problem Failure to Auto Stop (2938)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2021
Event Type  malfunction  
Event Description
During surgery at skull perforation to achieve access to operative site.The surgeon reported to the surgical tech assisting and myself in the room to make the coordinator aware that the midas rex safety feature malfunctioned.Typically, the drill will stop to prevent injury to the brain, however, it did not stop.Doctor did report that no injury to the patient occurred.Perforator disposable piece medtronic easy drill cranial perforator: ref# dm0010faa, perforator reusable drill attachment: (b)(4), medtronic reusable drill handpiece: (b)(4), medtronic drill machine on neuro cart with drills and bovies; serial number: (b)(4).
 
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Brand Name
EASYDRILL CRANIAL PERFORATOR 14 X 11 X 3MM
Type of Device
DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
Manufacturer (Section D)
MICROMAR INDÚSTRIA E COMÉRCIO LTDA
12343 nw 25th street
coral springs FL 33065
MDR Report Key11559598
MDR Text Key241949437
Report Number11559598
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDM0010FAA
Device Catalogue NumberDM0010FAA
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/22/2021
Event Location Hospital
Date Report to Manufacturer03/24/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age17155 DA
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