BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRADA COLONIC OVERTUBE

    MDR report key: 3955177 · Received July 18, 2014

    Report

    Report Number
    1528319-2014-00011
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    January 24, 2012
    Report Date
    July 18, 2014
    Manufacturer
    UNITED STATES ENDOSCOPY GROUP, INC.
    Product Code
    FDF
    PMA / PMN Number
    K092221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT LOT NUMBER WAS NOT PROVIDED, AND THE TERM 'DISLOCATION' WAS NOT FURTHER EXPLAINED. THE STATUS OF THE PATIENT POST-INTERVENTION WAS NOT PROVIDED. IN RESPONSE TO A US ENDOSCOPY REQUEST FOR ADDITIONAL INFORMATION, THE DISTRIBUTOR CONFIRMED THAT IT FIRST BECAME AWARE OF THE ADVERSE EVENT ON (B)(4) 2014, 30 MONTHS AFTER THE REPORTED EVENT OCCURRED. THE DISTRIBUTOR HAD NO FURTHER INFORMATION CONCERNING THE EVENT. THE DEVICE IS INDICATED FOR USE WITH A COLONOSCOPE TO PREVENT THE REFORMATION OF THE SIGMOID LOOP SUBSEQUENT TO THE REDUCTIO OF THE CURVATURE OF THE SIGMOID COLON BY THE COLONOSCOPE DURING COLONOSCOPY. THE DEVICE IS INTENDED TO PROVIDE FOR EASY ADVANCEMENT OF THE COLONOSCOPE WHILE MINIMIZING MUCOSAL PINCHING. THE DEVICE CONSISTS OF A SINGULAR, CLEAR TUBE WITH A DISTAL TAPERED TIP, AND AN IRRIGATION LINE AT THE PROXIMAL HANDLE. THE HANDLE CONFIGURATION INCLUDES GRIP FEATURES FOR EASE OF GRASPING, AND THE HANDLE PROVIDES A POSITIVE STOP AT THE PROXIMAL END OF THE TUBE. SPECIFICALLY THE IFU PROVIDES THAT ONCE THE DESIRED DEPTH OF INSERTION WITH THE ENTRADA COLONIC OVERTUBE IS ACHIEVED, AN ASSIGNMENT MUST HOLD THE DEVICE IN THIS POSITION AT ALL TIMES TO PREVENT INWARD AND OUTWARD MIGRATION. A REVIEW OF COMPLAINT HISTORY ((B)(4) 2010 - (B)(4) 2014) FINDS NO COMPLAINTS WHICH INCLUDE A DESCRIPTION SIMILAR TO 'DISLOCATION' (SUCH AS BREAKAGE, MIGRATION). THE REVIEW ALSO FINDS NO COMPLAINTS WERE ASSOCIATED WITH PATIENT HARM. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON JULY 16, 2014, AN ADVERSE EVENT ASSOCIATED WITH THE ENTRADA COLONIC OVERTUBE (00711145) WAS COMMUNICATED TO A US ENDOSCOPY SALES MANAGER BY A DISTRIBUTOR IN (B)(6). THE DISTRIBUTOR WAS NOTIFIED OF THE ADVERSE EVENT ON JULY 10, 2014. ACCORDING TO THE NOTIFICATION LETTER PROVIDED TO THE DISTRIBUTOR, THE ADVERSE EVENT OCCURRED ON (B)(6) 2012 DURING A SCREENING COLONOSCOPY. THE NOTIFICATION DESCRIBES CONDITION OF ELONGATED SIGMOID COLON AND INCOMPLETE ADVANCEMENT OF THE ENDOSCOPE. THE NOTIFICATION STATES THAT COMPLICATIONS OCCURRED DURING USE OF THE DEVICE, RESULTING IN DISLOCATION OF THE DEVICE. THE NOTIFICATION STATES THAT ENDOSCOPIC RETRIEVAL WAS NOT ACHIEVED BECAUSE THE DEVICE HAD BECOME STUCK IN THE SIGMOID COLON, AND FURTHER STATES THAT THE DEVICE WAS REMOVED VIA SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423150 ENTRADA COLONIC OVERTUBE COLONIC OVERTUBE FDF UNITED STATES ENDOSCOPY GROUP, INC. 00711145 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention