BEUDAMED
    FDA Adverse Event Other Summary report: N

    M103S-PLK PTD BULK SP

    MDR report key: 3733372 · Received March 26, 2014

    Report

    Report Number
    1017768-2014-00010
    Event Type
    Other
    Date Received
    March 26, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SYRINGE. THE CUSTOMER REPORTS THE LPN WAS TOLD THAT DURING THE HYDRODISSECTION PORTION OF THE CATARACT SURGERY, THE CANNULA CAME OFF AND RIPPED ACROSS THE ENDOTHELIUM. IN THE SURGEON'S OPINION THE DEVICE CAUSED/CONTRIBUTED TO THE EVENT. THE PATIENT'S EYE WILL HAVE A PERMANENT ENDOTHELIAL TUCK OR SCAR ON THE LEFT EYE. THE CUSTOMER DESCRIBED THE EVENT; AT THE END OF THE PHACO, SHE WAS PREPARING TO INJECT BSS INTO THE MAIN 2MM CORNEAL INCISION/WOUND LIP TO HELP SEAL IT, THE CANNULA SLIPPED IN THE WOUND LIP AGAINST THE ANTERIOR CORNEAL LIP, THE CANNULA SHOT OFF THE SYRINGE AND HIT THE PC IOL; CORNEAL ENDOTHELIUM IN THE VISUAL AXIS IMMEDIATELY, UNABLE TO READ, SHOWING THE TUCK; SHE REMOVED THE CANNULA FROM THE EYE; WOUND WAS CHECKED AND FOUND TO BE WATER TIGHT. THIS CANNULA WAS CHECKED FOR SECURITY PRIOR TO HANDLING IT OFF TO THE SURGEON BY THE SCRUB TECH; ALSO WAS CHECKED BY THE SURGEON PRIOR TO SQUIRTING IN THE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176823 M103S-PLK PTD BULK SP SYRINGE FMF COVIDIEN 8881103066 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other