BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUILL KNOTLESS ISSUE CLOSUR DEVICE

    MDR report key: 3214112 · Received July 3, 2013

    Report

    Report Number
    3008845715-2013-00005
    Event Type
    Other
    Date Received
    July 3, 2013
    Date of Event
    June 3, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SURGICAL SPECIALITIES PUERTO RICO INC. DBA ANGIOTECH
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS MOMENT, SAMPLES HAVE NOT BEEN RETURNED TO SURGICAL SPECIALITIES PUERTO RICO, INC. DBA ANGIOTECH FOR EVALUATION. H6: METHOD: AT THIS MOMENT SAMPLES HAVE NOT BEEN RETURNED TO SURGICAL SPECIALITIES PUERTO RICO, INC. DBA ANGIOTECH FOR EVALUATION. RESULTS/CONCLUSIONS: AT THIS MOMENT SAMPLES HAVE NOT BEEN RETURNED TO SURGICAL SPECIALITIES PUERTO RICO, INC. DBA ANGIOTECH FOR EVALUATION. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT WAS RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. AVAILABLE INVENTORY OF FINISHED GOOD PRODUCT MANUFACTURED WITH THE SAME NEEDLE COMPONENT LOT WAS TRANSFERRED TO THE QUARANTINE WAREHOUSE FOR EVALUATION PURPOSES. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. (B)(4). ITEM #RA-1067Q, QUILL KNOTLESS TISSUE CLOSURE DEVICE 2T9-0-PDO 36 X 36, LOT MQ09260.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE USING QUILL PDO PRODUCT, CUSTOMER STATES THAT THE NEEDLE BROKE OFF INTO THE PT'S ABDOMEN. XRAY CONFIRMED THE PRESENCE OF THE NEEDLE. SURGERY WAS CONVERTED FROM A LAPAROSCOPIC PROCEDURE TO AN OPEN PROCEDURE TO AN OPEN PROCEDURE TO RETRIEVE THE NEEDLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306491 QUILL KNOTLESS ISSUE CLOSUR DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALITIES PUERTO RICO INC. DBA ANGIOTECH RA-1067Q MQ09260

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention NONE MADE AVAILABLE.