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

Model Number 2001T-10

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 02/27/2018

Event Type  malfunction  

Event Description

Blade broke off in patient, was able to recover.

Manufacturer Narrative

The following sections referenced below were corrected: the 'date of event' was inadvertently recorded incorrectly on the initial report of this mdr. The date was changed from (b)(6) 2018 to the correct date of (b)(6) 2018 (as reflected in this follow-up report). Providing information about the 'operator of device; physician selected. The initial reporter of this event to the importer did not provided whether they reported this event being discussed to the fda; therefore, 'unknown' was selected in this section. Providing clarification of the date the 'report sent to manufacturer'; date changed from 03/27/2018 to the correct date of 03/29/2018 (as reflected in this follow-up report). This mdr will be updated as pertinent information is received about this event.

Event Description

Blade broke off in patient, was able to recover.

• 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: 7375137
• MDR Text Key: 103661115
• Report Number: 1058382-2018-00003
• 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

• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/01/2021
• Device Model Number: 2001T-10
• Device Lot Number: 160908AC
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2018
• Distributor Facility Aware Date: 03/27/2018
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2018
• 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?

Type of Device Usage