BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH STEALTH ENDOSCOPIC/ CONVENTIONAL CIRCULAR STAP

    MDR report key: 283761 · Received June 26, 2000

    Report

    Report Number
    1527736-2000-02787
    Event Type
    Malfunction
    Date Received
    June 26, 2000
    Date of Event
    June 7, 2000
    Report Date
    June 7, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) ECS29 WAS USED DURING A SIGMOIDECTOMY PROCEDURE. IT WAS REPORTED BY THE REP AFTER INSERTING PROXIMAL ANVIL IN PROXIMAL BOWEL, SURGEON USED A PURSE STRING DEVICE TO SECURE ANVIL. THE ECS29 WAS INSERTED RECTALLY. THE TROCAR WAS DIRECTED ANTERIOR TO THE STAPLE LINE IN THE DISTAL BOWEL. THE RN ASSISTANT WAS DOING THIS UNDER SUPERVISION. AFTER THE ORANGE LINE CAME THROUGH, THE ANVIL WAS THEN CONNECTED TO THE TROCAR. THE RN ASSISTANT DIALED THE INSTRUMENT TOGETHER, IN THE MIDDLE OF THE GAP SETTING SCALE. THE RN ASSISTANT THEN FIRED THE INSTRUMENT AND ROTATED DIAL CONTROL CLOCK WISE SEVERAL TURNS BEFORE REMOVING INSTRUMENT RECTALLY. DURING IRRIGATION A LEAK IN THE POSTERIOR WALL WAS DETECTED. THE SURGEON REPAIRED THE LEAK WITH VICRYL/SUTURE. THE ANASTOMOSIS WAS THEN RE-CHECKED AFTER THE REPAIR WITH IRRIGATION AND NO LEAK WAS FOUND. THE SURGEON STATED IT WAS LIKE THE STAPLE DID NOT FORM POSTERIORLY THERE WAS NO CONSEQUENCE TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH STEALTH ENDOSCOPIC/ CONVENTIONAL CIRCULAR STAP CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY - ALB NA M4FU7A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other