BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURSTRING

    MDR report key: 7083627 · Received December 5, 2017

    Report

    Report Number
    2647580-2017-08324
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    November 17, 2017
    Report Date
    December 5, 2017
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDJ
    UDI-DI
    10884521051478
    PMA / PMN Number
    K901107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A TOTAL GASTRECTOMY/R-Y PROCEDURE, THE SURGEON SET THE DEVICE ON THE TISSUE AND TRIED TO SQUEEZE THE RING HANDLES FOR LOCKING, HOWEVER THE SHAFT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO NOTED PROBLEM TO PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863929 PURSTRING CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY GDJ US SURGICAL PUERTO RICO 020730 10884521051478

    Patients

    Seq Age Sex Outcome Treatment
    1