BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIUM STAPLE

    MDR report key: 69939 · Received February 10, 1997

    Report

    Report Number
    1825883-1997-00002
    Event Type
    Malfunction
    Date Received
    February 10, 1997
    Date of Event
    December 20, 1996
    Report Date
    February 8, 1997
    Manufacturer
    INSTRUMENT MAKAR, INC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MEDIUM STAPLE WAS BEING MADE TO ATTACH A LIGAMENT. TWO STAPLES WERE BENT WHILE BEING USED. THE THIRD STAPLE BROKE PART WAY DOWN ONE TIME. THE PIECE WAS RECOVERED. THE PHYSICIAN WENT TO THE LARGE STAPLE AND WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIUM STAPLE STAPLE GAG INSTRUMENT MAKAR, INC 10757 31624

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN