BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROSS OTG GASTROSTOMY KIT WITH T-FASTENERS

    MDR report key: 757177 · Received September 1, 2006

    Report

    Report Number
    1528738-2006-00016
    Event Type
    Injury
    Date Received
    September 1, 2006
    Date of Event
    August 10, 2006
    Report Date
    August 11, 2006
    Manufacturer
    ROSS PRODUCTS DIVISION, ABBOTT LABORATORIES
    Product Code
    KNT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT, A PHYSICIAN, REPORTED THAT WHEN HE WAS ATTEMPTING TO REMOVE A 14 FR NICEFLO SACKS-VINE GASTROSTOMY TUBE, SLIGO LIST #M181 (SIMILAR TO THE ROSS PEG TUBE, LIST #226) HE INTENTIONALLY CUT THE TUBE. THE PHYSICIAN REPORTED THAT HE EXPECTED THE BUMPER TO PASS THROUGH THE PATIENT'S GI TRACT, AS CUTTING THE TUBE FROM THE BUMPER HAS BEEN HIS PRACTICE IN THE PAST. IN THIS CASE, THE SEVERED BUMPER DID NOT PASS THROUGH THE PATIENT'S GI TRACT, BUT RATHER RESULTED IN A MECHANICAL OBSTRUCTION OF THE ILEUM. THE BUMPER WAS THEN REMOVED FROM THE PATIENT SURGICALLY. THE PATIENT WAS REPORTED TO HAVE A MEDICAL HISTORY OF CANCER OF THE LARGE INTESTINE. NO OTHER PATIENT INFORMATION WAS PROVIDED. THIS IS CONSIDERED AN ADVERSE EVENT RELATED TO DISREGARDING THE INSTRUCTIONS FOR USE AND REMOVAL OF THE DEVICE, WHICH IS USE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROSS OTG GASTROSTOMY KIT WITH T-FASTENERS 78 KNT TUBES, GASTROINTESTINAL AND ACCESSORIES KNT ROSS PRODUCTS DIVISION, ABBOTT LABORATORIES 226 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R