BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOVE-GRUENWALD PITUITARY RONGUER 5" STRAIGHT

    MDR report key: 497329 · Received November 18, 2003

    Report

    Report Number
    2430952-2003-00014
    Event Type
    Malfunction
    Date Received
    November 18, 2003
    Report Date
    November 18, 2003
    Manufacturer
    TONTARRA MEDIZINTECHNIK GMBH
    Product Code
    HAE
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INSTRUMENT WAS SENT TO THE REPAIR CENTER FOR EVALUATION AND REPAIR BY THE DISTRIBUTOR. THE DISTRIBUTOR INDICATED ON THE RETURN FORM THAT THIS INSTRUMENT BROKE DURING THE SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED IN 2003. TO DATE NO FURTHER DETAILS WERE PROVIDED. THE INSTRUMENT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOVE-GRUENWALD PITUITARY RONGUER 5" STRAIGHT JARIT NEURO/SPINAL SURGICAL INSTRUMENT HAE TONTARRA MEDIZINTECHNIK GMBH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *