BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION * SURG DEV, SHEARS, ENDOSCOPIC

    MDR report key: 2142435 · Received June 28, 2011

    Report

    Report Number
    3005075853-2011-02633
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    April 27, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PACKAGE HAD VISIBLE HAIR INSIDE THE PACKAGE AND WAS ACROSS THE PATH OF THE SEAL CAUSING A BREAK IN THE STERILE BARRIER OF THE PACKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PRODUCT PACKAGING WAS INSPECTED AND A LONG (HUMAN) HAIR WAS SEEN TO BE INSIDE. THE PACKAGING WAS NOT OPENED. THE PROCEDURE WAS CARRIED OUT USING ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION * SURG DEV, SHEARS, ENDOSCOPIC ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK E4LZ4R

    Patients

    Seq Age Sex Outcome Treatment
    1