BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5X100MM KII FIOS FIRST ENTRY ADVANCED FIXATION

    MDR report key: 3113225 · Received May 8, 2013

    Report

    Report Number
    2027111-2013-00167
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 6, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RA HAS JUST RECEIVED THE FOREIGN OBJECT AND HAS BEEN ASSIGNED TO ENGINEERING FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP HYSTERECTOMY - "DURING THE SURGERY, THE DOCTOR FOUND WHAT LOOKS LIKE A PIECE OF PAPER. NO ONE SAW THE PRODUCT FALL OUT OF A TROCAR, THEY ASSUME IT CAME FROM THE TROCAR. THE FOREIGN OBJECT WAS SENT TO THE LAB FOR ANALYSIS AND SENT BACK TO (B)(6) IN OPERATING ROOM SO I COULD SEND TO YOU. BELOW IS THE LIST OF TROCARS USED. CFF03 - # 1184727. CFS02 - 1186768, CFF33 - 1184740. THE PATIENT DID HAVE SURGERY IN THE PAST BY THE SAME SURGEON. I WILL SEND THE FOREIGN BODY TO YOU FOR ANALYSIS." PATIENT STATUS: PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202334 5X100MM KII FIOS FIRST ENTRY ADVANCED FIXATION NONE GCJ APPLIED MEDICAL CFF03 1184727

    Patients

    Seq Age Sex Outcome Treatment
    1 CFF33, 11X100 KII FIOS ADVFIX 6/BX LOT# 1184740| CFS02, 5X100 KII SLEEVE ADVFIX 12/BX LOT# 1186768