BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPOINT

    MDR report key: 2738846 · Received September 6, 2012

    Report

    Report Number
    3008845715-2012-00005
    Event Type
    Other
    Date Received
    September 6, 2012
    Date of Event
    July 13, 2012
    Report Date
    September 4, 2012
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH
    Product Code
    HNN
    PMA / PMN Number
    K822112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INFORMED THAT NO SAMPLES WILL BE RETURNED TO SURGICAL SPECIALTIES (B)(4) ANGIOTECH FOR EVAL. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT NUMBER REPORTED OR FINISHED GOOD PRODUCT MFG WITH THE SAME BLADE COMPONENT LOT AVAILABLE. THEREFORE, NO TESTING CAN BE PERFORMED. METHOD: THE DEVICE WAS NOT AVAILABLE FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. RESULTS/CONCLUSION: THE DEVICE WAS NOT RETURNED TO SURGICAL SPECIALITIES (B)(4) ANGIOTECH FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED FOR CORRESPONDING ISSUES IDENTIFIED DURING THE MFG PROCESSES OR AT FINAL INSPECTION. FINISHED GOOD PRODUCT WAS RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. REF: COMPLAINT # (B)(4), ITEM # 72-2831, SHARPOINT, SLIT FULL HDL-2.8MM ANG C-CUT, LOT MASD990.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: "DURING SURGERY, A SMALL METALLIC PIECE WAS PRESENT ON THE KNIFE BLADE AND HAS COME OUT WITHIN THE EYE OF THE PT UNDER THE CORNEA." INTERVENTION MAY BE NEEDED TO REMOVE THE PIECE OF METAL FROM THE PT'S CORNEA. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPOINT SLIT FULL HDL-2.8MM ANG C-CUT HNN SURGICAL SPECIALTIES PUERTO RICO INC. DBA ANGIOTECH 72-2831 MASD990

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other NONE MADE AVAILABLE.