MICROMAR INDUSTRIA E COMERCIO LTDA EASYDRILL PERFORATOR; DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
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Model Number DM0010FAA |
Device Problem
Device Remains Activated (1525)
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Patient Problems
Bruise/Contusion (1754); Contusion (1787)
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Event Date 09/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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No conclusion can be drawn.No evaluation was performed, as the device was not returned.If the device is returned in the future, product analysis may be performed.This dm0010faa easydrill cranial perforator with lot number 1640/19 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.
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Event Description
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It was reported that during trepanation for drainage of the temporal region, the automatic safety mechanism of the perforator did not work which resulted to cerebral contusion.It was also added that there was a delay in the procedure.On follow-up, it was reported that the cerebral parenchyma was treated during the delay.There was no further information that can be provided regarding the status of the patient post-surgery.
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Manufacturer Narrative
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Report not confirmed.Evaluation could not reproduce the reported malfunction of continues to run.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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