BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELLA PUNCH NEURO RONGEUR

    MDR report key: 1053014 · Received May 21, 2008

    Report

    Report Number
    1053014
    Event Type
    Other
    Date Received
    May 21, 2008
    Date of Event
    March 27, 2008
    Report Date
    May 21, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HTX
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS DISCOVERED IN THE PROCESS OF CLEANING THIS SURGICAL EQUIPMENT, THAT DUE TO THE WAY IT IS DESIGNED, THERE ARE PARTS/SECTIONS THAT DO NOT GET CLEAN DURING THE CLEANING PROCESS. THE INSTRUMENTS ARE TAKEN APART TO BE CLEANED, WHICH REQUIRED THE CLEANING PROCESSES TO BE CHANGED AND ROUTINE MAINTENANCE TO BE PERFORMED MORE FREQUENTLY ON THESE DEVICES. THERE ARE SEVERAL MORE DEVICES AT THIS FACILITY THAT ARE DESIGNED SIMILAR TO THESE. PICTURES OF THE DEVICE CAN BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELLA PUNCH NEURO RONGEUR INSTRUMENT, SURGICAL HTX INTEGRA LIFESCIENCES CORPORATION 45-RB 5860 *

    Patients

    Seq Age Sex Outcome Treatment
    1