BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AL-III-DISS W/20' HOSE

    MDR report key: 3181533 · Received June 21, 2013

    Report

    Report Number
    1045834-2013-02501
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    GEI
    PMA / PMN Number
    K940535
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE ACTUAL DEVICES WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED CONDITION WAS DUPLICATED AND CONFIRMED. EVIDENCE INDICATES THIS WAS DUE TO IMPROPER HANDLING DURING CLEANING PROCEDURE. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE INSPECTION, IT WAS DISCOVERED THE FOOT CONTROL DEVICE WAS LEAKING OIL AND WATER IN THE CHAMBER. THE REPORTER CONFIRMED THAT THE EVENT DID NOT OCCUR DURING SURGERY; THERE WAS NO INJURIES OR MEDICAL INTERVENTION REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281879 AL-III-DISS W/20' HOSE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES-FOOT CONTROL GEI DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1