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

Model Number DM0010FAA

Device Problem Failure to Auto Stop (2938)

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 09/08/2017

Event Type  malfunction  

Event Description

While the surgeon was using the perforator to complete a burr hole (placement of deep brain stimulating leads), it failed to auto stop and plunged through the dura and penetrated the brain tissue.The patient had a right frontal intraparenchymal hemorrhage (iph).She was transferred to (b)(6) neuro rehab.She continued to rehabilitate and was discharged home with family weeks later.The device was sequestered.Manufacturer response for medtronic easy drill cranial perforator, (brand not provided) (per site reporter):.

• Brand Name: EASYDRILL CRANIAL PERFORATOR
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (COMPOUND, POWERED)
• Manufacturer (Section D): MICROMAR INDÚSTRIA E COMÉRCIO LTDA; deep pal; 4620 north beach street; ft worth TX 76137
• MDR Report Key: 7112466
• MDR Text Key: 94667748
• Report Number: 7112466
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2017,12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DM0010FAA
• Device Catalogue Number: DM0010FAA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR