MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR138)

Catalog Number 310138

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2014

Event Type  malfunction  

Event Description

It was reported 'the functionality of the endoscopic gatroc release system (egr) blade was tested before the device was inserted into the guide provided by the kit.The device worked properly when tested.Once the device was inserted into the guide, during surgery, there was some movement as the surgeon tried to align the blade with the sit in the guide.Once it was properly aligned, the surgeon attempted to deploy the blade which worked but the surgeon was unable to recess the blade back into the device when needed.The blade was stuck in the deployed position.There was no patient injury or adverse consequence alleged.The surgery was delayed for 5 minutes due to this issue'.

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR138)
• Type of Device: ENDOSCOPIC GASTROC RELEASE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; cincinnati OH
• Manufacturer Contact: caren finkelstein ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3963459
• MDR Text Key: 4627109
• Report Number: 3004608878-2014-00061
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310138
• Device Lot Number: PA0016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1