BEUDAMED
    FDA Adverse Event Injury Summary report: N

    133650 PREMIUM SURGICLIP III 9.0

    MDR report key: 6449359 · Received March 31, 2017

    Report

    Report Number
    2647580-2017-05187
    Event Type
    Injury
    Date Received
    March 31, 2017
    Report Date
    March 16, 2017
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    FZP
    PMA / PMN Number
    K142869
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: AFTER AN OPEN PROCEDURE TO THE SUBMAXILLARY GLAND, THE PATIENT EXPERIENCED INTERNAL HEMORRHAGING. THE CLIPS WERE REPORTED TO HAVE CLAMPED PERFECTLY ON THE FACIAL ARTERIOVENOUS PACKAGE, HOWEVER, AFTER THE REOPERATION THE REPORTER QUESTIONS IF THE CLIPS DID NOT CLAMP PERFECTLY BECAUSE THE VEINS AND ARTERIES WERE VERY THIN. CURRENT PATIENT STATUS IS ALIVE, WITH INJURY. THE EVENT EXTENDED PATIENT HOSPITALIZATION AND SURGICAL TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED :ACCORDING TO THE REPORTER: THE REASON FOR SURGERY WAS SUBMAZILLITIS. THE CLIP DID NOT PERFORM BECAUSE THERE WAS AN INTERNAL HEMORRHAGE. THE CLAMP VESSELS WERE APPROXIMATELY 3-4MM. THE PATIENT WAS WITHIN A FEW MINUTES OF REACHING THE REA AND HAD TO BE REFERRED TO THE EMERGENCY ROOM BECAUSE THE DRAINAGE HAD A VERY LARGE AMOUNT OF BLOOD. TO RESOLVE THE CONDITION THE SURGEON USED A MANUAL SUTRUE TO LIGATE THE VESSEL. THE REOPERATION WAS DONE THE SAME DAY AS THE ORIGINAL PROCEDURE. CURRENT PATIENT STATUS IS ALIVE, WITH INJURY. THE FINDINGS DURING THE REOPERATION WERE THE SURGEON SAW THAT THE CLIPS HAS NOT WORKED WELL. THEY KNEW THE CLIPS DID NOT WORK CORRECTLY . THE PATIENT WAS DISCHARGED AND SHE WAS IN PERFECT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233381 133650 PREMIUM SURGICLIP III 9.0 CLIP, IMPLANTABLE FZP US SURGICAL PUERTO RICO 133650 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R