BEUDAMED
    FDA Adverse Event Summary report: N

    DISPOSABLE ENDOCUT SCISSORS TIP

    MDR report key: 2222714 · Received August 3, 2011

    Report

    Report Number
    1223422-2011-00004
    Date Received
    August 3, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MICROLINE SURGICAL
    Product Code
    GEI
    PMA / PMN Number
    K962119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE ENDOCUT SCISSORS TIP WAS NOT RETURNED; THEREFORE NO INVESTIGATION COULD BE CONDUCTED. NO LOT NUMBER WAS PROVIDED; THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. MICROLINE HAS BEEN INFORMED BY THE MANUFACTURER THAT THE SILICONE BAND IS NOT RADIO OPAQUE AND IS NOT INTENDED FOR IMPLANTATION GREATER THAN TWENTY-NINE DAYS. THE WHITE PIGMENT IS FDA COMPLIANT. THE COMPOUND IS FREE OF PHTHALATE PLASTICISERS. THE SILICONE BAND IS A MEDICAL GRADE SILICONE THAT MEETS THE REQUIREMENTS OF (B)(4) BIOLOGICAL TESTING, AS WELL AS FDA CODE OF FEDERAL REGULATIONS TITLE 21 177.2600 FOR FOOD AND DRUGS, AS WELL AS THE (B)(4).

    Description of Event or Problem · 1

    THE TECHNICIAN DID NOT TAKE THE WHITE PROTECTIVE BAND OFF THE DISPOSABLE SCISSORS TIP. THE DOCTOR NOTICED IT ON CAMERA AND TRIED TO TAKE THE HANDLE AND SCISSORS TIP OUT OF THE PATIENT. UPON REMOVING THE HANDLE AND TIP, HE NOTICED THAT THE WHITE BAND HAD FALLEN OFF INTO THE PATIENT. THE DOCTOR DECIDED THAT HE DID NOT WANT TO GO SEARCHING AROUND BECAUSE THE PATIENT WAS 22 WEEKS PREGNANT. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE ENDOCUT SCISSORS TIP SCISSORS TIP GEI MICROLINE SURGICAL 3142 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1