BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESD FLEXIBLE ENDOSCOPIC SUTURING DEVICE

    MDR report key: 493870 · Received November 3, 2003

    Report

    Report Number
    1320468-2003-00001
    Event Type
    Injury
    Date Received
    November 3, 2003
    Report Date
    October 27, 2003
    Manufacturer
    LSI SOLUTIONS, INC.
    Product Code
    MFJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN WAS USING A WILSON-COOK ESD FLEXIBLE ENDOSCOPIC SUTURING DEVICE (MFG BY LSI SOLUTIONS). DURING RECOVERY FROM GENERAL ANESTHESIA, THE PT REPORTED CHEST DISCOMFORT. A SMALL PERFORATION OF THE ESOPHAGUS WAS REPORTEDLY FOUND DURING A FOLLOW-UP EXAMINATION BY X-RAY CONTRAST STUDY. THE WILSON-COOK REPORT STATED PT WAS REFERRED TO SURGERY, WHERE THE PERFORATION WAS REPORTEDLY REPAIRED LAPAROSCOPICALLY. THE PERFORATION OF THE ESOPHAGUS APPARENTLY HEALED WELL AND NO FURTHER PROBLEMS WERE REPORTED. AFTER FURTHER REVIEW OF THE PROCEDURE VIDEO BY THE INITIAL REPORTER, HE CONCLUDED THAT THE PERFORATION MOST LIKELY OCCURRED WHEN THE FLEXIBLE SEW-RIGHT DEVICE WAS ADVANCED INTO THE ESOPHAGUS. THE ENDOSCOPE WAS LOCATED AT THE DISTAL END OF THE ESOPHAGUS AT THE TIME OF THE EVENT. WHEN RESISTANCE WAS MET DURING SEW-RIGHT DEVICE ADVANCEMENT, THE USER APPARENTLY CONTINUED FORWARD ADVANCEMENT OF THE SEW-RIGHT DEVICE, CAUSING THE SEW-RIGHT DEVICE TO EXIT THE DISTAL END OF THE EXTERNAL ACCESSORY CHANNEL FORCEFULLY ENOUGH TO DISRUPT THE WALL OF THE ESOPHAGUS. IT WAS STATED THAT THE ENDOSCOPE WAS ANGLED BECAUSE THE PT'S ESOPHAGUS WAS ANGLED MORE THAN NORMAL. THE PT'S ESOPHAGUS 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 SUTURE PLACEMENT DEVICE AND ACCESSORIES MFJ LSI SOLUTIONS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention