BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESD FLEXIBLE ENDOSCOPIC SUTURING DEVICE

    MDR report key: 488524 · Received October 10, 2003

    Report

    Report Number
    1037905-2003-00096
    Event Type
    Injury
    Date Received
    October 10, 2003
    Report Date
    November 14, 2002
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING RECOVERY FROM GENERAL ANESTHESIA, THE PT REPORTED CHEST DISCOMFORT. A SMALL PERFORATAION OF THE ESOPHAGUS WAS CONFIRMED DURING A FOLLOW-UP EXAMINATION, WHERE AN X-RAY CONTRAST STUDY WAS PERFORMED. THE PT WAS REFERRED TO SURGERY WHERE THE PERFORATION WAS REPAIRED LAPAROSCOPICALLY. THE PERFORATION OF THE ESOPHAGUS HEALED PROPERLY AND NO FURTHER INJURY WAS REPORTED. AFTER FURTHER REVIEW OF THE PROCEDURE VIDEO, THE INITIAL REPORTER CONCLUDED THAT THE PERFORATION MOST LIKELY OCCURRED WHEN THE FLEXIBLE SEW-RIGHT DEVICE WAS ADVANCED INTO THE ESOPHAGUS. AT THIS TIME, THE ENDOSCOPE WAS LOCATED AT THE DISTAL END OF THE ESOPHAGUS. WHEN RESISTANCE WAS MET DURING SEW-RIGHT DEVICE ADVANCEMENT, THE USER CONTINUED WITH FORCE. WHEN THE RESISTANCE SUBSIDED, THE DEVICE EXITED THE DISTAL END OF THE EXTERNAL ACCESSORY CHANNEL FORCEFULLY. ADDITIONAL INFO PROVIDED WITH THIS REPORT INDICATED THE POSITION OF THE ENDOSCOPE WAS ANGLED BECAUSE THE PT'S ESOPAHGUS WAS ANGLED MORE THAN NORMAL. ALSO, THE PT'S ESOPHAGEAL TISSUE WAS DESCRIBED AS EXTREMELY FRAGILE WHERE THE PERFORATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESD FLEXIBLE ENDOSCOPIC SUTURING DEVICE SUTURING DEVICES AND ACCESSORIES GCJ WILSON-COOK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention