BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAJ-2207 IRRIGATION TUBING CO2 PK10

    MDR report key: 15370157 · Received September 7, 2022

    Report

    Report Number
    2429304-2022-00043
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    August 10, 2022
    Report Date
    September 15, 2022
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD
    Product Code
    OCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, DURING A COLONOSCOPY, THE MAJ-2207 TUBING MANY HAVE BECOME KINKED CAUSING EXCESS PRESSURE AND A BLEEDING INJURY TO THE PATIENT. THE TUBING WAS CONNECTED TO OFP-2 PUMP. A REQUEST FOR ADDITIONAL INFORMATION IS IN PROGRESS. THIS EVENT INCLUDES 2 REPORTS AS FOLLOWS: (B)(6): K10035002. (B)(6): K10001141. THIS REPORT IS 1 OF 2 FOR (B)(6): K10035002.

    Description of Event or Problem · 0

    THE CUSTOMER RESPONDED TO OUR REQUEST FOR ADDITIONAL INFORMATION. AT THE BEGINNING OF THE DIAGNOSTIC COLONOSCOPY, THE PATIENT'S BLEEDING WAS IN THE COLON. THE BLEEDING WAS IRRIGATED AND THE PRESSURE OF THE OFP-2 WAS TURNED DOWN. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME SUBJECT DEVICE. THERE WAS A SMALL DELAY OF THREE (3) MINUTES WHILE INSPECTING THE PUMP AND TURNING DOWN THE OFP-2. THE CUSTOMER SUSPECTS THE TUBING MAY HAVE BEEN KINKED BY THE WATER BOTTLE PLACEMENT ON THE CART. THE SUBJECT DEVICE WAS INSPECTED PRIOR TO USE AND NO ISSUES IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399893 MAJ-2207 IRRIGATION TUBING CO2 PK10 OLYMPUS FLUSHING PUMP OCX KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LTD K10035002 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O K10001141, UNK LOT