BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLICATOR

    MDR report key: 2216408 · Received February 12, 2007

    Report

    Report Number
    1226693-2007-00001
    Event Type
    Injury
    Date Received
    February 12, 2007
    Date of Event
    January 11, 2007
    Report Date
    January 22, 2007
    Manufacturer
    NDO SURGICAL, INC.
    Product Code
    KOG
    PMA / PMN Number
    K032820
    Removal / Correction Number
    1226693-1/26/07-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLICATOR. PLICATOR IMPLANT CARTRIDGE. (B)(4) 2007. CATALOG # - 160-01130, LOT # - 05-337, OTHER # - REF: (B)(4). ADDITIONAL INFORMATION FROM THE USER FACILITY REPORT: EPS PLICATOR INSTRUMENT; ENDOSCOPE/ACCESSORY; (B)(4).

    Description of Event or Problem · 1

    PATIENT UNDER WENT ENDOSCOPIC UPPER GASTROINTESTINAL PANENDOSCOPY WITH ENDOSCOPIC PLICATION. THE ENDOSCOPIC PLICATOR WAS PASSED INTO POSITION WITHOUT DIFFICULTY BY THE SURGEON. THE GUIDE WIRE WAS REMOVED AND THE SMALL CHANNEL ENDOSCOPE THEN PASSED THROUGH THE PLICATOR INTO THE STOMACH. BOTH INSTRUMENTS WERE RETROFLEXED AND THEN APPROACHED THE ANGLE OF H.I.S. IN STANDARD FASHION. THE TISSUE RETRACTOR WAS USED TO ENGAGE THE MUSCLE AT THE ANGLE OF H.I.S., AND THEN THE JAWS. THE INSTRUMENT WAS THEN ROTATED IN A CLOCK WISE FASHION INSIDE THE PATIENT AND THE JAWS CLOSED. THE PLICATOR WAS FIRED AND THE JAWS FAILED TO OPEN. AFTER SEVERAL ATTEMPTS, NDO SURGICAL WAS CALLED FOR ASSISTANCE. SEVERAL ATTEMPTS WERE MADE TO DISLODGE THE PLICATOR, ALL OF WHICH FAILED. THE DECISION TO PROCEED WITH OPEN SURGICAL INTERVENTION WAS MADE AFTER ALL ATTEMPTS TO EXTRACT THE PLICATOR HAD FAILED. DURING A PLICATOR PROCEDURE, THE IMPLANT WAS DEPLOYED, HOWEVER, SUBSEQUENT TO IMPLANT DEPLOYMENT, THE PLICATOR INSTRUMENTS ARMS COULD NOT BE OPENED. CONVENTIONAL ATTEMPTS TO RECOVER FROM THIS SITUATION FAILED AND THE PATIENT UNDERWENT AN EXPLORATORY LAPAROTOMY TO EXTRICATE, THE PLICATOR INSTRUMENT FROM THE PATIENT'S STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLICATOR ENDOSCOPIC SURGICAL DEVICE KOG NDO SURGICAL, INC. 05-0390

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R