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

Model Number 2001T-15

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Date 01/25/2018

Event Type  malfunction  

Event Description

It was reported the blade broke off inside a patient's brain.

Manufacturer Narrative

Information in the referenced 'blocks' below was added/corrected within this mdr follow-up report: 'no' is being selected to clarify this single-use device was not reprocessed. (lot# and expiration date) - during the follow-up, the customer provided the importer with the lot# of the reported defective device; therefore, the identification of the device's expiration was able to be determined. The lot# (171309ac) and expiration date (01aug2022) of the reported device has been added to this follow-up mdr report. The follow-up# has been updated to reflect the sequence of this follow-up mdr report being submitted. The 'date of this report' is being updated to reflect today's submission of this follow-up mdr report. Due to the reporting of the lot# from the customer, the 'approximate age of the device' (6 months) was able to be determined. Therefore, the approximate age of the device is being added to this follow-up mdr report. The date 'report sent to fda' reflects today's date for the submission of this mdr follow-up report to the fda. The date 'report sent to manufacturer' reflects today's date for the submission of this mdr follow-up report to the manufacturer. The manufacturer's email was inadvertently omitted and is being added to this mdr follow-up report. This mdr follow-up report includes the mfr report#, therefore, this section is being completed where applicable. This mdr follow-up report includes the mfr report#, therefore, this section is being completed where applicable. Manufacturer's narrative: the manufacturer, niraj industries pvt. Ltd. Was notified of the complaint reported as highlighted within this mdr report. Due to the customer failing to provide the manufacturer with the actual device, the manufacturer could not conduct an appropriate investigation to examine the reported device. However, the manufacturer took remedial action to examine retain sample of the reported complaint batch located at their facility. As all the device characteristics (i. E. Hardness, stiffness, handle fitting, sharpness) that can induce blade breakage were observed to be within specification. The exact cause of the complaint cannot be established in absence of the defective sample. The most probable cause of blade breakage could be excessive application of lateral force during procedure or any other abnormal use conditions. As a cautionary measure, all the concerned persons have been educated to take care of all possibilities of blade breakage during process & inspection. Based off the manufacturer's investigation results provided above, we are moving to close this complaint file and consider this mdr closed.

Event Description

The blade broke off right at the base in back of the patient. An xray was taken and showed that the blade was in fact in the patient and they went through 2 hours to remove after 3 hour surgery. When they were trying to remove the blade, it keeps sliding forward which pierced through the spinal cord but there was no permanent damage.

• 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: 7284037
• MDR Text Key: 194149469
• Report Number: 8040409-2018-00002
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/20/2016,01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2001T-15
• Device Lot Number: 171309AC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2016
• Distributor Facility Aware Date: 01/26/2018
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2018
• Date Manufacturer Received: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 02/20/2018 Patient Sequence Number: 1