• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROMAR INDUSTRIA E COMERCIO LTDA EASYDRILL PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROMAR INDUSTRIA E COMERCIO LTDA EASYDRILL PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU Back to Search Results
Model Number DM0010FAA
Device Problem Device Remains Activated (1525)
Patient Problem Perforation (2001)
Event Date 06/30/2021
Event Type  Injury  
Manufacturer Narrative
No conclusion can be drawn.No evaluation was performed, as the device was discarded.This dm0010faa easydrill cranial perforator with unknown lot number was manufactured by micromar.Multiple warnings are included in the easydrill cranial perforator ifu manual including: it is essential to keep the drill perpendicular (90°) at the predetermined point of the skull to be drilled, as an excessive deviation from perpendicularity may cause the product to fail and lead to serious patient injury.Select a drill bit suitable for the bone thickness.This prevents the drill from tearing the bone or brain tissue (similar effect when the bit is not positioned at 90°).If the components of the easydrill cranial perforator become loose during trephination, discontinue use.The drill can cut or tear the dura mater when it unlocks.Check some conditions before performing the procedure, such as the existence of adhering dura mater or other anomalies adjacent to the drilling site.We will continue to track and trend this complaint type.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during trepanation for an implantation of electrodes for the treatment of essential tremor, the perforator did not stop rotating which resulted to two dural breaches on the two drill holes made.It was also reported that the procedure was completed using the reported device and the device was discarded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EASYDRILL PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOU
Manufacturer (Section D)
MICROMAR INDUSTRIA E COMERCIO LTDA
cnpj: 53.168.142/0001-29
av. marginal ao corrego da ser
sao paulo,sp 09980 -39
BR  09980-39
Manufacturer (Section G)
MICROMAR INDUSTRIA E COMERCIO LTDA
cnpj: 53.168.142/0001-29
av. marginal ao corrego da ser
sao paulo,sp 09980 -39
BR   09980-39
Manufacturer Contact
natalia matos
cnpj: 53.168.142/0001-29
av. marginal ao corrego da ser
sao paulo,sp 09980--39
BR   09980-39
140575722
MDR Report Key12271633
MDR Text Key264960552
Report Number1625507-2021-00265
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K141455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/03/2021
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 Model NumberDM0010FAA
Device Catalogue NumberDM0010FAA
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/08/2021
Initial Date FDA Received08/03/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age69 YR
Patient Weight65
-
-