BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE I L S INTRALUMINAL STAPLER

    MDR report key: 317852 · Received February 26, 2001

    Report

    Report Number
    1527736-2001-00860
    Event Type
    Malfunction
    Date Received
    February 26, 2001
    Date of Event
    February 5, 2001
    Report Date
    February 6, 2001
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS RPEORTED THAT (1) CDH29 WAS USED DURING A ILEONANAL POUCH PROCEDURE. IT WAS REPORTED BY THE REP THAT AFTER USING PURSE STRING DEVICE TO PLACE ANVIL INTO PROXIMAL BOWEL, SURGEON TRIED TO MARRY ANVIL TO TROCAR IN DISTAL BOWEL. THE ANVIL HEAD WOULD NOT LOCK ONTO TROCAR. THE SURGEON HELD ANVIL ONTO TROCAR WHILE TIGHTENING IT DOWN. AFTER THE DEVICE WAS MORE THAN HALFWAY CLOSED THE ANVIL STAYED ON THE TROCAR WITHOUT BEING HELD ON. THE SURGEON FIRED DEVICE. THE DONUTS WERE CHECKED. ONE WAS INCOMPLETE SO THE SURGEON OVERSEWED AND COMPLETED THE CASE. THERE WAS NO CONSEQUENCE TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7619 PROXIMATE I L S INTRALUMINAL STAPLER CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY - ALB NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other