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
Hematoma (1884)
|
Event Date 08/03/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Report inconclusive.The device has been returned and is still pending their evaluation results.This dm0010faa easydrill cranial perforator with lot number 071/18 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.(b)(6).If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that disposable portion of the easy drill did not stop perforating and went right to the brain.The perforator should have stopped once it broke through the bone but did not stop.It was reported that there was no patient impact.On follow-up, it was reported that the dura got cut and the patient had subdural hematoma.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|