BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOLOK CLIP

    MDR report key: 3908414 · Received June 2, 2014

    Report

    Report Number
    3003898360-2014-00354
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    January 1, 2009
    Report Date
    May 1, 2014
    Manufacturer
    UNK
    Product Code
    MCH
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ARVIND GANPULA AND ET AL HAD AN ARTICLE IN THE INDIAN J UROL, 2010 ALLEGING MIGRATION OF THE HEM-O-LOK CLIP. THE DEVICE HISTORY RECORD REVIEW (DHR) COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: ARVIND GANPULA AND ET AL HAD AN ARTICLE IN THE INDIAN J UROL, 2010 DESCRIBING A CARE REPORT WHERE A (B)(6) YEAR OLD MALE PATIENT UNDERWENT LAPAROSCOPIC RADICAL PROSTATECTOMY (LRP) FOR LOCALIZED CARCINOMA PROSTATE. THE URETHROVESCIAL ANASTOMOSIS WAS PERFORMED. FOLLOWING THE RETRIEVAL OF SPECIMEN, AN ARTERIAL BLEEDER NEAR THE TRANSECTED URETHRA WAS SECURED WITH HEM-O-LOK CLIP. THREE MONTHS AFTER THE SURGERY, THE PATIENT PRESENTED WITH OBSTRUCTIVE LOWER URINARY TRACT SYMPTOMS. AN ASCENDING URETHROGRAM REVEALED OBSTRUCTION AT THE LEVEL OF BLADDER NECK. ON CYSTOSCOPY, THE ANTERIOR URETHRA WAS NORMAL. THERE WAS A NARROWING, AT THE ANASTOMOTIC SITE AND TWO HEM-A-LOK CLIPS WERE SEEN PROTRUDING IN THE URETHRA. CLIPS WERE REMOVED WITH FORCEPS AND THE ANASTOMOTIC SEGMENT DILATED WITH A BALLOON DILATOR. POSTOPERATIVELY, HE VOIDED WITH A GOOD FLOW. SUBSEQUENTLY, HE REQUIRED RECYSTOSCOPY AND URETHRAL BALLOON DILATATION AT 2 YEAR'S FOLLOW UP FOR THE RECURRENCE OF LUTS AND NOW REMAINS ASYMPTOMATIC AT 3 YEARS POST-LRP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322227 HEMOLOK CLIP HEMOCLIPCS MCH UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1