MAUDE Adverse Event Report: M/S NIRAJ INDUSTRIES PVT LTD. GLASSVAN SURGICAL BLADE

Catalog Number 2001T-15

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/14/2018

Event Type  malfunction  

Event Description

It was reported that the #15 surgical blade broke during the removal of impacted 3rd molars of the female patient. The broken blade (fragment) was quickly recovered from the patient's mouth and no further medical intervention or additional treatment was needed due to this issue.

• Brand Name: GLASSVAN
• Type of Device: SURGICAL BLADE
• Manufacturer (Section D): M/S NIRAJ INDUSTRIES PVT LTD.; plot 177, sector 25; ballabgarth, 12100 4; IN 121004
• MDR Report Key: 7531889
• MDR Text Key: 108982832
• Report Number: 1058382-2018-00004
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: 2001T-15
• Device Lot Number: 171611AC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/21/2018
• Distributor Facility Aware Date: 05/11/2018
• Device Age: 6 MO
• Event Location: Other
• Date Report to Manufacturer: 05/16/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage