BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECARE MORCELLEX* TISSUE MORCELLATOR

    MDR report key: 2883049 · Received December 21, 2012

    Report

    Report Number
    2210968-2012-08378
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 11, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    HET
    PMA / PMN Number
    K100280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. UPON EVALUATION, THE SEALING AREA ALONG THE PERIPHERY OF BLISTER PACKAGING WAS CAREFULLY EXAMINED; EVALUATOR DID NOT FIND ANY EVIDENCE OF PRESENCE OF HAIR. THE DEVICE OPERATED AS INTENDED DURING EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). HAIR IN SEAL. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC MYOMECTOMY ON (B)(6) 2012. BEFORE THE PACKAGE WAS OPENED, A HAIR ABOUT 20 CM, WAS FOUND STUCK AT THE SEALED AREA OF THE PACKAGE BETWEEN THE TYVEK AND THE BLISTER PACKAGE. THE PRODUCT WAS NOT USED FOR THE PATIENT NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE MORCELLEX* TISSUE MORCELLATOR LAPAROSCOPE, GYNECOLOGIC HET ETHICON, INC. NA MT216993

    Patients

    Seq Age Sex Outcome Treatment
    1