BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURSTRING

    MDR report key: 6966132 · Received October 20, 2017

    Report

    Report Number
    2647580-2017-07287
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    September 20, 2017
    Report Date
    December 18, 2017
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDJ
    UDI-DI
    10884521051478
    PMA / PMN Number
    K901107
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE PUSHERS ARE FULLY DEPLOYED. CARTRIDGES ARE PROPERLY SEATED AFTER FIRING. NO VISUAL ABNORMALITIES. THE CONDITION OF THE DEVICE PRECLUDES FUNCTIONAL TESTING. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL GASTRECTOMY/R-Y PROCEDURE, THE SURGEON CLAMPED THE TISSUE OF ESOPHAGUS, AND THEN TRIED TO PULL THE PURSE-STRING SUTURE OUT, HOWEVER IT WAS STUCK ON SOMETHING AND COULD NOT PULL IT OUT. THEN THE SURGEON REMOVED THE DEVICE FROM THE TISSUE, AND RESECTED THE TISSUE ADDITIONALLY AND RE-SUTURED IT. THERE WAS TISSUE DAMAGE. THE PATIENT IS IN GOOD CONDITION POST-SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746330 PURSTRING CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY GDJ US SURGICAL PUERTO RICO 020730 P3L0401X 10884521051478

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R