MAUDE Adverse Event Report: M/S NIRAJ INDUSTRIES PVT LTD, PLOT 177 GLASSVAN PLUS; BLADE CARTRIDGE

Model Number 0249X

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Date 06/01/2015

Event Type  Injury  

Event Description

While affixing the blade cartridge on the scalpel handle, the technician was cut by the blade and required two (2) stitches.The event occurred prior to patient treatment.The technician reportedly placed her finger over the sheath opening while installing the device and subsequently applied enough force when pressing down to lock the blade in place on the handle to activate the sheath exposing the blade tip.This method of installation was in direct contradiction to the instructions for use, as well as the training the technician received prior to using the device.

Manufacturer Narrative

Test document only; all previous test data removed to clear record.We consider this mdr closed.

Event Description

*let it be known that this is a test submission and all information is not to be filed as an fda mdr submission.

• Brand Name: GLASSVAN PLUS
• Type of Device: BLADE CARTRIDGE
• Manufacturer (Section D): M/S NIRAJ INDUSTRIES PVT LTD, PLOT 177; sector 25; ballabgarhfaridabad
• MDR Report Key: 4908115
• MDR Text Key: 15830557
• Report Number: 1058382-2015-00001
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown,unknown
• Type of Report: Initial,Followup
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 0249X
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2015
• Distributor Facility Aware Date: 06/12/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other