BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSTITCH

    MDR report key: 1970638 · Received August 19, 2010

    Report

    Report Number
    1970638
    Event Type
    Injury
    Date Received
    August 19, 2010
    Date of Event
    June 9, 2010
    Report Date
    August 18, 2010
    Manufacturer
    COVIDIEN LP
    Product Code
    OCW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PT WAS IN THE OR FOR REMOVAL OF A COMPLEX TUMOR AT THE GASTROESOPHAGEAL (GE) JUNCTION, ON THE ANTERIOR WALL. DURING THE PROCEDURE THE ENDO STITCH MISFIRED, POSSIBLY LODGING A NEEDLE IN THE GASTRIC WALL. THE AREA WAS OVERSEWN AT THE TIME. THE NEXT DAY, THE PT COMPLAINED OF BACK PAIN. A SWALLOW STUDY REVEALED A LEAK. THE PT WAS TAKEN BACK TO THE OR FOR A LAPAROSCOPIC REPAIR OF THE LEAK.

    Description of Event or Problem · 1

    A PT WAS IN THE OR FOR REMOVAL OF A COMPLEX TUMOR AT THE GASTROESOPHAGEAL (GE) JUNTION, ON THE ANTERIOR WALL. DURING THE PROCEDURE THE ENDO STITCH MISFIRED, POSSIBLY LODGING A NEEDLE IN THE GASTRIC WALL. THE AREA WAS OVERSEWN AT THE TIME. THE NEXT DAY, THE PT COMPLAINED OF BACK PAIN. A SWALLOW STUDY REVEALED A LEAK. THE PT WAS TAKEN BACK TO THE OR FOR A LAPAROSCOPIC REPAIR OF THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSTITCH SUTURE DEVICE OCW COVIDIEN LP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R