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

Catalog Number 310138

Device Problem Retraction Problem (1536)

Patient Problem Tissue Damage (2104)

Event Date 05/15/2014

Event Type  Injury  

Event Description

This is the first report of two reports concerning the same pt and same surgery date.This report concerns the endoscopic gastroc release system lot number pa0016.It was reported "blades would not retract.This happened during endoscopic gastroc recession surgery.Cut skin when exiting the wound.(this) required more sutures than usual".On (b)(6) 2014 additional info was received from the reporter.The pt had surgery on both feet using two egr systems.The surgeon had the same issue with (2) egr blades that did not retract.The pt was cut on both feet.One wound was reported as "worse" than the other but the specific lot number of the specific foot related to the "worse" event was not known by the surgeon or the reporter.

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 drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3893595
• MDR Text Key: 4425018
• Report Number: 3004608878-2014-00077
• 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: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310138
• Device Lot Number: PA0016
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2014
• Initial Date FDA Received: 06/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR