BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK CLIP

    MDR report key: 3963208 · Received May 20, 2014

    Report

    Report Number
    3003898360-2014-00315
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 1, 2014
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    MCH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. COMPLAINT CAN NOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION; THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    SATYA ALLAPARTHI, MD DIV OF UROLOGY, DEPT OF SURGERY, UNIV OF MA MED SCH. WROTE THE FOLLOWING ARTICLE FOUND IN THE INTERNET JOURNAL OF UROLOGY, 2009: A (B)(6) GENTLEMAN PRESENTED TO OUR INSTITUTION WITH A DIAGNOSIS OF STAGE T2A PROSTATE CANCER. WE USED STANDARD 5-PORT TRANSPERITONEAL APPROACH. INTRA OPERATIVELY THE PATIENT HAD A PROMINENT MEDIAN LOBE, WHICH WAS INCLUDED IN THE DISSECTION, AND THE POSTERIOR WALL OF THE BLADDER INCISED. WE MET WITH CONSIDERABLE DIFFICULTY DISSECTING THE AMPULLA AND THE SEMINAL VESICLES IN THIS AREA THAT SEEMED TO BE TOTALLY SCARRED, AND THE ANATOMY WAS LESS THAN OBVIOUS. TO ACHIEVE HEMOSTASIA A COMBINATION OF METICULOUS DISSECTION, BIPOLAR CAUTERY AND HOLC USED JUDICIOUSLY. HIS POSTOPERATIVE RECOVERY COURSE WAS UNREMARKABLE. EIGHTEEN MONTHS AFTER THE SURGERY THE PATIENT PRESENTED WITH INITIATIVE LOWER URINARY TRACT SYMPTOMS (LUTS) PREDOMINANTLY URGENCY AND FREQUENCY WITH MINIMAL POST VOID RESIDUAL. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN DEMONSTRATED CALCULUS IN THE BLADDER. RIGID CYSTOSCOPY CONFIRMED A 1 CM CALCULUS AROUND THE HOLC AT BLADDER NECK REGION. HOLMIUM LASER CYSTOLITHOPAXY WAS USED TO FRAGMENT THE STONE AND HOLC WAS SUCCESSFULLY REMOVED, USING AN ALLIGATOR GRASPER. PATIENT HAD NO RESIDUAL LOWER URINARY TRACT SYMPTOMS AT THE END OF 3 MONTHS. CURRENT PATIENT CONDITION UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298395 HEMOLOK CLIP MCH INTUITIVE SURGICAL 428053 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1