BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLICATOR

    MDR report key: 860863 · Received March 9, 2007

    Report

    Report Number
    1226693-2007-00002
    Event Type
    Malfunction
    Date Received
    March 9, 2007
    Date of Event
    June 12, 2006
    Report Date
    March 9, 2007
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    KOG
    PMA / PMN Number
    K032820
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INTERVIEW OF SITE PERSONNEL: THE STAFF PRESENT DURING THE INITIAL TREATMENT PROCEDURE REPORT THAT THE CARTRIDGE MAY HAVE BEEN DETACHED FROM THE INSTRUMENT ARM PRIOR TO THE IMPLANT DEPLOYMENT BEING COMPLETED. THE TREATING PHYSICIAN WAS REPORTEDLY VERY AGGRESSIVE WHEN TORQUING THE PLICATOR INSTRUMENT AND THIS MAY HAVE RESULTED IN MISALIGNMENT OF THE IMPLANT CARTRIDGES AND/OR PARTIAL SEPARATION OF ONE OF THE CARTRIDGES FROM THE INSTRUMENT ARM THEREBY RESULTING IN A 1T DEPLOYMENT OUTCOME. INSPECTION OF PRODUCT: THE INSTRUMENT WAS NOT RETURNED ON AN RA, AND WAS THEREFORE, NOT AVAILABLE FOR INSPECTION. ON 12/4/06, REP, NDO FIELD TRAINER, VISUALLY INSPECTED THE CARTRIDGE THAT WAS RETRIEVED FROM THE PT. THE CARTRIDGE EVIDENCED A BROKEN TAB WHICH WOULD BE CONSISTENT WITH THE CARTRIDGE PULLING OFF OF THE INSTRUMENT. DHR REVIEW: BECAUSE THE IMPLANT AND INSTRUMENT LOT AND SERIAL NUMBERS ARE UNK, NO DHR REVIEW IS POSSIBLE. CONCLUSIONS: THERE IS NO APPARENT PRODUCT MALFUNCTION IN THIS INSTANCE. THE INSTRUMENT THAT WAS INVOLVED IN THE 1T DEPLOY OUTCOME, IMMEDIATELY THEREAFTER, SUCCESSFULLY DEPLOYED A PLICATOR IMPLANT, SO NO INSTRUMENT MALFUNCTION IS LIKELY. THE RECOVERED IMPLANT CARTRIDGE EVIDENCED A BROKEN TAB. THE TIMING OF THIS BROKEN TAB IS UNCERTAIN, HOWEVER, TECHNICIANS ARE INSTRUCTED TO VISUALLY CONFIRM TAB INTEGRITY AS PART OF THE CARTRIDE LOADING PROCEDURE. IT IS MOST LIKELY THAT THE CARTRIDGE TAB BROKE EITHER DURING THE CARTRIDGE DEPLOYMENT EFFORT (IN WHICH CASE THE CARTRIDGE MAY HAVE BECOME PARTIALLY SEPARATED FROM THE INSTRUMENT ARM THEREBY CAUSING THE 1T DEPLOY) OR SUBSEQUENTLY IF THE PHYSICIAN INAPPROPRIATELY ATTEMPTED TO FREE THE TETHERED CARTRIDGE BY TWISTING THE INSTRUMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WILL BE IMPLEMENTED AT THIS TIME. APPROPRIATE RECOVERY TECHNIQUES HAVE BEEN REVIEWED WITH THE PHYSICIAN AND RETRAINING ON APPROPRIATE TREATMENT TECHNIQUE HAS ALSO BEEN ACCOMPLISHED.

    Description of Event or Problem · 1

    DURING PLICATOR GERD TREATMENT, PARTIAL IMPLANT DEPLOYMENT OCCURRED AND THE PLICATOR IMPLANT CARTRIDGE WAS TETHERED TO THE STOMACH WALL. THEREAFTER, THE PT EXPERIENCED INTERMITTENT STOMACH PAIN (WHICH THE PHYSICIAN FELT WAS UNRELATED TO THE TETHERED CARTRIDGE) AND COMPLAINED OF PSYCHOLOGICAL DISTRESS. THE TETHERED CARTRIDGE WAS ENDOSCOPICALLY RETRIEVED FROM THE PT IN 2006, AND THE PT HAS NO FURTHER ISSUES. ALTHOUGH THE PT'S REPORTED STOMACH PAIN WAS NOT DISABLING AND THE PHYSICIAN DID NOT FEEL THAT THE PT WAS "SERIOUSLY INJURED", THE CO IS CONSERVATIVELY INTERPRETING THE TERM "SERIOUS INJURY" TO ENCOMPASS THE INADVERTENT TETHERING OF THE CARTRIDGE TO THE GASTRIC WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLICATOR ENDOSCOPE/ACCESSORY KOG NDO SURGICAL, INC. 160-01130 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention