BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAW INS. BULLET NOSE GRASPER 5MM 310MM

    MDR report key: 4436210 · Received January 13, 2015

    Report

    Report Number
    2916714-2015-00015
    Event Type
    Malfunction
    Date Received
    January 13, 2015
    Date of Event
    December 5, 2014
    Report Date
    January 13, 2015
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GEI
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510 (K) #K010752/K940936. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    ASSEMBLED DEVICE IS PO190R. DEVICE BROKE DURING PROCEDURE. ONE PART OF THE JAWS BROKE OFF. SURGICAL DELAY OF 15 MINUTES. DEVICE COMPONENTS INCLUDE: PO735R/JAW INS. BULLET NOSE GRASPER 5MM 310MM, PM973R/INSULATED OUTER TUBE 5/5MM 310MM, PO958R/MONOPOLAR HANDLE WITHOUT RATCHET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30885 JAW INS. BULLET NOSE GRASPER 5MM 310MM GRASPER GEI AESCULAP AG & CO. KG PO735R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other