BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTICULATOR ENDO MINI-SHEARS 5MM INSTR

    MDR report key: 1010122 · Received March 10, 2008

    Report

    Report Number
    2647580-2008-00136
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 19, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GCJ
    PMA / PMN Number
    K914752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE AND PT SEX: UNK. ACCORDING TO THE REPORTER: THE DEVICE WOULD NOT UN-ARTICULATE AND IT WAS DIFFICULT TO REMOVE FROM TROCAR. THE DISTAL END OF THE SHAFT WAS TORN. THE DEVICE WAS NOT USED FOR THE REST OF THE CASE AND NO REPORT OF PT INJURY WAS DONE. THE SURGERY TIME WAS NOT EXTENDED SIGNIFICANTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTICULATOR ENDO MINI-SHEARS 5MM INSTR SURGICAL HAND INSTRUMENT GCJ PONCE - USS P7L0472

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK