MAUDE Adverse Event Report: NIRAJ INDUSTRIES PVT LTD. GLASSVAN®; BLADE

Model Number 2001T-15

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 01/26/2018

Event Type  malfunction  

Event Description

The blade broke off inside a patient's brain.

• Brand Name: GLASSVAN®
• Type of Device: BLADE
• Manufacturer (Section D): NIRAJ INDUSTRIES PVT LTD.; plot 177, sector 25; ballabgarth, faridabad haryana 12100 4; IN 121004
• MDR Report Key: 7221700
• MDR Text Key: 98538452
• Report Number: 1058382-2018-00002
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 2001T-15
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/26/2018
• Distributor Facility Aware Date: 01/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1