BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURSTRING

    MDR report key: 7083774 · Received December 5, 2017

    Report

    Report Number
    2647580-2017-08326
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    November 6, 2017
    Report Date
    December 5, 2017
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDJ
    UDI-DI
    20884521051475
    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.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DEVICE WAS USED FOR ANASTOMOSIS AT ESOPHAGECTOMY. THE THREAD BROKE. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862586 PURSTRING CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY GDJ US SURGICAL PUERTO RICO 020730 P7G1250X 20884521051475

    Patients

    Seq Age Sex Outcome Treatment
    1