BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN STD FORCEPS 20CMX1.0MM

    MDR report key: 6552992 · Received May 8, 2017

    Report

    Report Number
    0001811755-2017-01225
    Event Type
    Malfunction
    Date Received
    May 8, 2017
    Date of Event
    March 1, 2017
    Report Date
    October 13, 2017
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GEI
    UDI-DI
    1088670406547
    PMA / PMN Number
    K121426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INFORMATION, AS REPORTED: CODMAN CATALOG NUMBER 80-1273, SPETZLER MALIS DISP FORCEP 8"L 1.0MM.

    Additional Manufacturer Narrative · 1

    USER FACILITY DECLINED PRODUCT RETURN.

    Description of Event or Problem · 1

    THE DEVICE TIP HAD BROKEN AND DISASSEMBLED, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    THE DEVICE TIP HAD BROKEN AND DISASSEMBLED, POSING THE RISK OF A SMALL COMPONENT BEING LOST IN A SURGICAL SITE, DURING A PROCEDURE AT THE USER FACILITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333752 CODMAN STD FORCEPS 20CMX1.0MM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER INSTRUMENTS-KALAMAZOO 1088670406547

    Patients

    Seq Age Sex Outcome Treatment
    1