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

Catalog Number 310138

Device Problems Retraction Problem (1536); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2014

Event Type  malfunction  

Event Description

It was reported the doctor engaged the endoscopic gastroc release system blade to make his cut and despite multiple efforts, the blade would not retract.Upon removal, the scrub tech tried to close and it was very difficult to close.There was no injury or adverse consequence to the pt reported.

Manufacturer Narrative

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

• Brand Name: ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR138)
• Type of Device: ENDOSCOPIC GASTROC RELEASE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer Contact: caren finkelstein ; 315 enterprise dr.; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4023914
• MDR Text Key: 4879857
• Report Number: 3004608878-2014-00132
• 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: Physician
• Type of Report: Initial
• Report Date: 07/24/2014

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: PA0017
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2014
• Initial Date FDA Received: 08/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9 YR