BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM SURGICLIP* M-9.75 TITANIUM

    MDR report key: 4665401 · Received April 7, 2015

    Report

    Report Number
    2647580-2015-00263
    Event Type
    Injury
    Date Received
    April 7, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 24, 2015
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    FZP
    PMA / PMN Number
    K853650
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT SENT TO FDA ON 04/07/2015.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT: THE FIRST TWO OR THREE CLIPS FORMED AND LOADED FINE BUT A FOURTH CLIP MALFORMED AFTER LOADING CORRECTLY AND THEN THE SUBSEQUENT CLIPS CONTINUED TO LOAD AT AN ANGLE IN THE JAWS. SOME ISSUES WITH THE CLIP FORMING, THE CLIPS WERE SCISSORING. SWITCHED TO ANOTHER 134044 DEVICE. THIS DEVICE HAD EXCESS CHALKY RESIDUE. SWITCHED TO 134053 DEVICE. CLIPS FELL INTO THE CAVITY OF THE PATIENT. THEY WERE PICKED OUT OR WASHED OUT BUT WHEN THE PATIENT WAS TAKEN BACK TO THEATRE LATER THERE WERE THREE CLIPS FLOATING IN THE WOUND. IT IS NOT CERTAIN WHETHER THESE CLIPS FELL FROM THE DEVICE OR CAME OFF THE VESSELS. NO TISSUE LOSS OR DAMAGE. SOME WEEPING FROM THE HEMATOMA DURING THE RE OPERATION. THE PATIENT SPENT 36 HOURS IN THE ICU BECAUSE THEY WERE CONCERNED ABOUT INTUBATING DUE TO THE SWELLING AND BRUISING.

    Description of Event or Problem · 1

    PROCEDURE: RIGHT HEMI THYROIDECTOMY ACCORDING TO THE REPORTER: THE SURGEON OBSERVED CLIP MALFORMATIONS DURING THE INITIAL FIRINGS OF THE CLIPS. HE SUBSEQUENTLY CHANGED TO A DIFFERENT DEVICE. THE OPERATING TIME WAS EXTENDED. THE INITIAL RESULTS OF THE PROCEDURE WERE CONSIDERED ACCEPTABLE BUT THE PATIENT WAS LATER BROUGHT BACK WITH POST OPERATIVE BLEEDING AT THE SURGICAL SITE. THE PATIENT UNDERWENT AN EMERGENCY PROCEDURE TO MANAGE SWELLING IN THE OPERATIVE AREA CAUSED BY THE BLEEDING. THE PATIENT IS RECOVERING. BLOOD LOSS WAS MINOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227261 PREMIUM SURGICLIP* M-9.75 TITANIUM DISPOSABLE CLIP APPLIER FZP COVIDIEN, FORMERLY USSC PUERTO RICO INC 134044 P4J0368X

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other