BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 4804434 · Received May 28, 2015

    Report

    Report Number
    3003898360-2015-00408
    Event Type
    Malfunction
    Date Received
    May 28, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 29, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE PROCODE IN SECTION D WAS CORRECTED TO FZP.

    Additional Manufacturer Narrative · 1

    QN#(B)(4). NO SAMPLE IS AVAILABLE FOR MFR TO EVALUATE.

    Description of Event or Problem · 1

    ALLEGED ISSUE: ON (B)(6) 2015, DR (B)(6) WAS PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY ON A PT. CLIPS WERE NOT "LOCKING" OVER STRUCTURE WHEN DISTAL END OF CLIP WAS CLEARED (NO TISSUE WAS IN THE WAY OF THE DISTAL END OF THE CLIP). PT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED ISSUE: ON (B)(6) 2015, DR. (B)(6) WAS PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY ON A PATIENT. CLIPS WERE NOT "LOCKING" OVER STRUCTURE WHEN DISTAL END OF CLIP WAS CLEARED (NO TISSUE WAS IN THE WAY OF THE DISTAL END OF THE CLIP). PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347675 AUTO ENDO5 ML APPLIER FZP TELEFLEX MEDICAL 73A1500441

    Patients

    Seq Age Sex Outcome Treatment
    1