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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR138)
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INTEGRA LIFESCIENCES CORPORATION OH/USA ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR138) Back to Search Results
Catalog Number 310138
Device Problems Retraction Problem (1536); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2014
Event Type  malfunction  
Event Description
It was reported the endoscopic gastroc release system blade got stuck and would not retract during surgery.There was no injury or adverse consequence to the patient or user reported.The device was discarded by the surgeon.
 
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported info.
 
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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 Key3928500
MDR Text Key4598561
Report Number3004608878-2014-00067
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number310138
Device Lot NumberPA0016
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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