BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL SRS

    MDR report key: 1028946 · Received April 11, 2008

    Report

    Report Number
    2522801-2008-00011
    Event Type
    Other
    Date Received
    April 11, 2008
    Date of Event
    February 20, 2008
    Report Date
    April 10, 2008
    Manufacturer
    SURGICAL SPECIALTIES (DBA ANGIOTECH)
    Product Code
    NEW
    PMA / PMN Number
    K071989
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK IF THE DEVICE INVOLVED IN THIS INCIDENT WAS EXPLANTED AS A RESULT OF THE INTERVENTION DESCRIBED. THE ACTUAL DEVICE INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR EVAL. ANOTHER DEVICE FROM THE SAME MFG LOT WAS AVAILABLE AND AN EVAL WAS PERFORMED. THE CUSTOMER REPORTED THE EVENT TO AN ANGIOTECH SALES REP ("COMPANY REP") WHO IN TURN REPORTED THE EVENT TO THE READING FACILITY COMPLAINT FUNCTION. ONE (1) STERILE DEVICE FROM THE SAME MFG LOT WAS AVAILABLE FOR EVAL. VISUAL ANALYSIS AND A NEEDLE PULL/TENSILE TEST WAS PERFORMED. VISUAL ANALYSIS AND THE NEEDLE PULL/TENSILE TEST PERFORMED WERE BOTH ACCEPTABLE (I.E., THE DEVICE MET SPECIFICATION). ANGIOTECH REFERENCE.

    Description of Event or Problem · 1

    DURING THE PROCEDURE ON THE PT'S BREAST, THE NEEDLE DETACHED AND WAS THOUGHT TO HAVE "FALLEN OFF THE FIELD." TOWARDS THE END OF THE PROCEDURE, THE MEDICAL STAFF COULD NOT LOCATE THE DETACHED NEEDLE. THE PT WAS X-RAYED AND THE NEEDLE WAS LOCATED IN THE PT'S BREAST. AS A RESULT, THE PT WAS MOVED BACK ONTO THE OPERATING TABLE AND THE NEEDLE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUILL SRS QUILL SRS NEW SURGICAL SPECIALTIES (DBA ANGIOTECH) RA-1036Q M260320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention