MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-27 for EASYDRILL PERFORATOR DM0010FAA manufactured by Micromar Industria E Comercio Ltda.
[168449231]
Report inconclusive. The device has been returned and is still pending their evaluation results. This dm0010faa easydrill cranial perforator with lot number 762/19 was manufactured by micromar. Device history record was reviewed by micromar and per their report, all the processes were executed according to what was planned and validated. There were no observations or nonconformities during the manufacturing process was reviewed. 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.
Patient Sequence No: 1, Text Type: N, H10
[168449232]
It was reported that during a craniotomy procedure, the perforator did not stop while creating a burr hole. On follow up, it was confirmed that the patient's dura was slightly damaged but the patient had no further issues post-surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625507-2019-00127 |
| MDR Report Key | 9382605 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-10-17 |
| Date Mfgr Received | 2019-10-30 |
| Date Added to Maude | 2019-11-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NATALIA MATOS |
| Manufacturer Street | CNPJ: 53.168.142/0001-29 AV. MARGINAL AO CORREGO DA SER |
| Manufacturer City | SAO PAULO,SP 09980-390 |
| Manufacturer Country | BR |
| Manufacturer Postal | 09980-390 |
| Manufacturer Phone | 140575722 |
| Manufacturer G1 | MICROMAR INDUSTRIA E COMERCIO LTDA |
| Manufacturer Street | CNPJ: 53.168.142/0001-29 AV. MARGINAL AO CORREGO DA SER |
| Manufacturer City | SAO PAULO,SP 09980-390 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 09980-390 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASYDRILL PERFORATOR |
| Generic Name | DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED) |
| Product Code | HBF |
| Date Received | 2019-11-27 |
| Returned To Mfg | 2019-11-08 |
| Model Number | DM0010FAA |
| Catalog Number | DM0010FAA |
| Lot Number | 762/19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROMAR INDUSTRIA E COMERCIO LTDA |
| Manufacturer Address | CNPJ: 53.168.142/0001-29 AV. MARGINAL AO CORREGO DA SER SAO PAULO,SP 09980-390 BR 09980-390 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-27 |