MAUDE Adverse Event Report: MICROMAR INDÚSTRIA EASYDRILL CRANIAL PERFORATOR; DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)

Model Number DM0010FAA

Device Problem Failure to Shut Off (2939)

Patient Problem Contusion (1787)

Event Date 04/01/2020

Event Type  malfunction  

Event Description

Doctor stated that the perforator failed to stop at dura level, which resulted in a dural contusion.Doctor stated that it is a known complication of the procedure and at this time the patient is stable.

• Brand Name: EASYDRILL CRANIAL PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): MICROMAR INDÚSTRIA; serraria, diadema, sao paolo
• MDR Report Key: 10046521
• MDR Text Key: 190649790
• Report Number: 10046521
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Device Lot Number: 1616/19
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA