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U.S. Department of Health and Human Services

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

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MICROMAR INDUSTRIA E COMERCIO LTDA EASYDRILL PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) Back to Search Results
Model Number DM0010FAA
Device Problem Device Remains Activated (1525)
Patient Problem Perforation (2001)
Event Date 09/25/2017
Event Type  Injury  
Manufacturer Narrative
Report inconclusive.The perforator has not been returned.If the device is returned, it will be forwarded to the manufacturer for evaluation.The device history records could not be reviewed by the manufacturer due to the lot number being unknown.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 monitor this complaint type for trends.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the easy drill perforator did not stop, causing a laceration to the dura.The ipc console was set at 60,000 rpm, but the surgeon indicated it never exceeded 30,000.It was reported there were no patient symptoms or complications associated with the event.On follow up it was confirmed the patient is doing fine without damage connected to the incident.The patient¿s injury did not have to be treated, nor does the patient require follow up.Patient identifier information was not provided.It was also reported the perforator was discarded.The first trepanation hole was completed without incident.The event occurred on the second trepanation.The surgeon completed an uneventful third trepanation.Concomitant models were provided; however, the serial numbers were unknown.
 
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Brand Name
EASYDRILL PERFORATOR
Type of Device
DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
Manufacturer (Section D)
MICROMAR INDUSTRIA E COMERCIO LTDA
cnpj: 53.168.142/0001-29
av. marginal ao corrego da ser
sao paulo,sp 09980 -390
BR  09980-390
Manufacturer (Section G)
MICROMAR INDUSTRIA E COMERCIO LTDA
cnpj: 53.168.142/0001-29
av. marginal ao corrego da ser
sao paulo,sp 09980 -390
BR   09980-390
Manufacturer Contact
natalia matos
cnpj: 53.168.142/0001-29
av. marginal ao corrego da ser
sao paulo,sp 09980--390
BR   09980-390
140575722
MDR Report Key6964498
MDR Text Key89809794
Report Number1625507-2017-00036
Device Sequence Number1
Product Code HBF
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K141455
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/20/2017
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? No
Device Operator Health Professional
Device Model NumberDM0010FAA
Device Catalogue NumberDM0010FAA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/25/2017
Initial Date FDA Received10/20/2017
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
Treatment
AD03 ATTACHMENT, S/N UNK, EM200, S/N UNK
Patient Outcome(s) Other;
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