BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUARDUS OVERTUBE

    MDR report key: 1772161 · Received July 24, 2010

    Report

    Report Number
    1528319-2010-00002
    Event Type
    Injury
    Date Received
    July 24, 2010
    Date of Event
    June 20, 2010
    Report Date
    July 23, 2010
    Manufacturer
    US ENDOSCOPY
    Product Code
    KOG
    PMA / PMN Number
    040836
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUARDUS OVERTUBE COMES IN TWO PIECES. THERE IS AN INNER TUBE AND AN OUTER TUBE THAT ARE JOINED TOGETHER, THE INSTRUCTIONS FOR USE DICTATE THAT THE OUTER TUBE IS TO BE USED WITH THE INNER TUBE, WHICH HAS A TAPERED TIP. PER CONVERSATIONS WITH THE FACILITY, IT HAS BEEN DETERMINED THAT THE OUTER TUBE WAS USED ALONE IN THIS INCIDENT.

    Description of Event or Problem · 1

    PATIENT ENTERED HOSPITAL ON (B)(6)2010 WITH A FOOD IMPACTION. SHE WAS ADMITTED OVERNIGHT, BUT AN ENDOSCOPY WAS NOT PERFORMED UNTIL THE NEXT DAY, (B)(6)2010. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE FOOD IMPACTION. THE PHYSICIAN THEN ATTEMPTED TO PERFORM AN ENDOSCOPY WITH A GUARDUS OVERTUBE. AFTER THE ENDOSCOPY, IT WAS NOTED THAT THERE WAS BLOOD IN THE ESOPHAGUS ALONG WITH SUBCUTANEOUS AIR IN THE CHEST AND NECK AREA. THE PATIENT UNDERWENT A CT SCAN AND WAS DIAGNOSED WITH A CERVICAL ESOPHAGEAL PERFORATION. THE PATIENT UNDERWENT SURGERY TO REPAIR THE PERFORATION AND WAS ADMITTED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUARDUS OVERTUBE OVERTUBE KOG US ENDOSCOPY 00711146

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention