MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ENDOSCOPIC GASTROC RELASE SYSTEM (EGR 138); ENDOSCOPIC GASTROC RELEASE

Catalog Number 310138

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported the egr device was tested before placing it inside the (patient's) leg to make the cut of the gastrocnemius aponeurosis.The egr device was in working order before placing inside the patient.Once the egr was in working order before placing inside the patient.Once the egr was placed inside the leg, the surgeon deployed the blade and was simply pulling the device back to make the cut.When he was at the end, he went to retract the blade in the down positon and the blade was stuck in the up position.The surgeon worked with the device to get the blade in the down positon and also flushed saline in the saline in the port several times but the blade remained in the up positon.There was a 15 minute delay in surgery and no injury to the patient, reported.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

• Brand Name: ENDOSCOPIC GASTROC RELASE SYSTEM (EGR 138)
• Type of Device: ENDOSCOPIC GASTROC RELEASE
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; cincinnati OH 45227
• Manufacturer Contact: rowena bunuan ; 315 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4260977
• MDR Text Key: 5048828
• Report Number: 3004608878-2014-00188
• 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: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2014
• 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: 36 YR