BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEM-O-LOK AUTO ENDO 5 APPLIER

    MDR report key: 847209 · Received October 12, 2006

    Report

    Report Number
    3003898360-2006-00021
    Event Type
    Malfunction
    Date Received
    October 12, 2006
    Date of Event
    September 1, 2006
    Report Date
    October 12, 2006
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR AND PRODUCT EVALUATION IS CURRENTLY IN PROCESS. ONCE THE EVALUATIONS ARE COMPLETE, TELEFLEX MEDICAL WILL PROVIDE A FOLLOW UP REPORT. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO TELEFLEX MEDICAL THAT DURING A GALL BLADDER RESECTION, THE APPLIER JAW FELL APART INTO THE PT. SURGEON WAS ABLE TO RETRIEVE THE JAW FROM THE SURGICAL FIELD. MINIMAL ADD'L TIME REQUIRED. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEM-O-LOK AUTO ENDO 5 APPLIER LIGATION CLIP APPLIER GDO TELEFLEX MEDICAL NA T1221076

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention