BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE X-TRACT MORCELLATOR

    MDR report key: 2223322 · Received August 25, 2011

    Report

    Report Number
    2210968-2011-01173
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ETHICON INC
    Product Code
    HET
    PMA / PMN Number
    K993801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE UNIT WAS NOTED TO HAVE CUSTOMER ABUSE. THE PEM STUD WAS MISSING. THE UNIT WAS UNABLE TO BE REPAIRED DUE TO S/N LABEL BEING ATTACHED TO SUBCHASSIS, WHICH COULD NOT BE REPAIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE MOTOR DRIVE UNIT WOULD NOT ACTIVATE. THE CUSTOMER FOUND A LOOSE CONNECTOR INSIDE THE UNIT. WHEN THEY RECONNECTED IT, THE MOTOR DRIVE UNIT WORKED. THE CASE WAS COMPLETED USING THE SAME MOTOR DRIVE UNIT WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE X-TRACT MORCELLATOR LAPAROSCOPIC MORCELLATOR HET ETHICON INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1