BEUDAMED
    FDA Adverse Event Other Summary report: N

    12X100MM KII OPTICAL ACCESS SYSTEM THREADED

    MDR report key: 2222793 · Received August 2, 2011

    Report

    Report Number
    2027111-2011-00083
    Event Type
    Other
    Date Received
    August 2, 2011
    Date of Event
    October 8, 2009
    Report Date
    August 2, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS NOT REPORTED TO APPLIED MEDICAL. WE RECEIVED MEDWATCH REPORT AND HAVE CONTACTED THE HOSPITAL TO REQUEST THE RETURN OF THE EVENT SAMPLE FOR OUR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: PLACEMENT OF LAPAROSCOPIC SIZE AP LARGE ADJUSTABLE GASTRIC BAND AND LAPAROSCOPIC HIATAL HERNIA REPAIR - "PT WAS ADMITTED WITH MORBID OBESITY FOR PLACEMENT OF LAPAROSCOPIC ADJUSTABLE GASTRIC BAND AND LAPAROSCOPIC HIATAL HERNIA REPAIR. AFTER THE SURGEON REPAIRED A 2 CM SLIDING TYPE HIATAL HERNIA WITH A SINGLE SUTURE, THE PORT WAS PLACED IN THE LEFT LOWER LOCATION. WHEN THE LEFT LOWER LAPAROSCOPE PORT WAS REMOVED, SURGEON NOTED A PIECE OF THE PLASTIC OF THE PORT HAD BROKEN OFF. THIS WAS FOUND IN THE WOUND AND THIS WAS REMOVED. THERE WAS A VERY SMALL 1 MM X 1 MM SILVER THAT SURGICAL TEAM WAS UNABLE TO FIND. THE SURGICAL TEAM THOROUGHLY INSPECTED THE WOUND, CHECKED THE DRAPES, BACK TABLE AND FLOOR TO SEE IF THE SILVER COULD BE FOUND (IT WAS NOT FOUND) AS WELL AS DOING A FOREIGN-BODY X-RAY FILM THAT SHOWED NO RADIOPAQUE FOREIGN BODY. SURGEON STATED IN THE OPERATIVE REPORT "IT IS VERY LIKELY THIS WAS MORE PROXIMALLY LOCATED ON THE PORT AND THAT THIS WAS ACTUALLY OUTSIDE OF THE BODY AND LIKELY ON THE DRAPES AROUND THE FIELD BUT WAS NOT ABLE TO IDENTIFIED. THE PT TOLERATED THE PROCEDURE WITHOUT COMPLICATION. THE PT WS DISCHARGED TO HOME THE DAY AFTER THE PROCEDURE ALERT, ORIENTED, AND IN NO DISTRESS. THE TROCAR PORT AND ONE PIECE WAS SAVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100MM KII OPTICAL ACCESS SYSTEM THREADED KII GCJ APPLIED MEDICAL C0R29 1094288

    Patients

    Seq Age Sex Outcome Treatment
    1 Other