BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOC PLUS ENDOTOUCH APPLIER 13" CVD

    MDR report key: 2715209 · Received August 22, 2012

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    1044475-2012-00110
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Date of Event
    July 12, 2012
    Report Date
    July 30, 2012
    Manufacturer
    TELEFLEX
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RECEIVED BY THE MANUFACTURER AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING LAPAROSCOPIC APPENDECTOMY, AFTER APPLYING FIRST CLIP WITH DIFFICULTY, SECOND CLIP COULDN'T BE APPLIED. INSTRUMENT IS VERY FREQUENTLY USED AND DUE TO NUMEROUS APPLICATIONS AND RE-STERILIZATIONS, JAWS BECAME LOOSE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOC PLUS ENDOTOUCH APPLIER 13" CVD ENDO APPLIER GDO TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1