BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPER, ALLIGATOR MAX

    MDR report key: 1587557 · Received January 12, 2010

    Report

    Report Number
    1219602-2010-00011
    Event Type
    Malfunction
    Date Received
    January 12, 2010
    Date of Event
    December 9, 2009
    Report Date
    December 11, 2009
    Manufacturer
    MANSFIELD MANUFACTURING SITE
    Product Code
    NBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. (B) (4).

    Description of Event or Problem · 1

    BOTTOM OF TIP BROKE OFF DURING SURGERY. SURGEON HAD TO MAKE AN EXTRA INCISION TO RETRIEVE THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRASPER, ALLIGATOR MAX GRASPER, ALLIGATOR MAX/ NBH NBH MANSFIELD MANUFACTURING SITE 011024 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention