BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR138)

    MDR report key: 3893594 · Received June 9, 2014

    Report

    Report Number
    3004608878-2014-00078
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    NBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF TWO REPORTS CONCERNING THE SAME PT AND SAME SURGERY DATE. (SEE MFG REPORT NUMBER # 3004608878-2014-00077). THIS REPORT CONCERNS THE ENDOSCOPIC GASTRIC 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334997 ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR138) ENDOSCOPIC GASTROC RELEASE NBH INTEGRA LIFESCIENCES CORPORATION OH/USA PA0017

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other