BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 7017596 · Received November 10, 2017

    Report

    Report Number
    1219930-2017-08639
    Event Type
    Malfunction
    Date Received
    November 10, 2017
    Date of Event
    July 13, 2017
    Report Date
    December 8, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    30884523003219
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, DOWNGRADED TO NOT REPORTABLE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE, THE DEVICE MISFIRED CAUSING 2 HOLES IN THE BOWEL. WHEN THE SPECIMEN WAS REMOVED THERE WAS A "HOLE NEXT TO THE STAPLE LINE" AND ALSO ON THE "COLOSTOMY END." THIS HOLE WAS THEN INCORPORATED INTO THE STOMA. THERE WAS TISSUE DAMAGE AS A RESULT OF THIS PROBLEM. THERE WAS A LINEAR CUT IN THE DISTAL END OF THE SPECIMEN ADJACENT TO THE STAPLE LINE. THIS WAS NOT FELT TO HAVE AFFECTED ONCOLOGICAL PROGNOSIS. A SIMILAR CUT OCCURRED IN THE DISTAL COLON AFTER EXCISING THE SPECIMEN BUT THIS DID NOT COMPROMISE THE OPERATION. THE DEVICE HAD POOR STAPLE FORMATION, LEADING TO AN INCOMPLETE STAPLE LINE. OVER SEWING WAS DONE TO RESOLVE THE ISSUE. A NEW STAPLER AND RELOAD WAS USED IN ORDER TO COMPLETE THE CASE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796900 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT N7C0246KX 30884523003219

    Patients

    Seq Age Sex Outcome Treatment
    1