BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFENDO A/W/SUCTION AND BIOPSY KIT

    MDR report key: 16885818 · Received May 8, 2023

    Report

    Report Number
    16885818
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    February 4, 2023
    Report Date
    April 18, 2023
    Manufacturer
    MEDIVATORS INC.
    Product Code
    ODC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEFENDO A/W/SUCTION AND BIOPSY KIT - THESE ARE ONE-TIME USE BUTTONS THAT ARE USED WITH SCOPES IN THE GL LAB. THE RED/ORANGE ONE CONTROLS THE SUCTION FUNCTION. OVER THE PAST TWO WEEKS, THIS BUTTON HAS BEEN GETTING STUCK, RESULTING IN CONSTANT SUCTION DURING ENDOSCOPIES. WHEN THE BUTTONS ARE TESTED (OUR PROCESS BEFORE EACH CASE), THEY FUNCTION NORMALLY. THAT IS ALSO THE CASE FOR THE BEGINNING OF THE PROCEDURE. IT USUALLY STARTS GETTING STUCK A FEW MINUTES IN, OR TOWARD THE END OF A SHORT CASE. THIS HAS HAPPENED ACROSS MULTIPLE SCOPES AND MULTIPLE PHYSICIANS. EACH PACKAGE INCLUDES 3 BUTTONS, AND THE RED/ORANGE ONE WAS THE PROBLEMATIC ONE. LOT # IS 558615. PICTURE IS ONLY TO SHOW THE PRODUCT , LOT NOT FAULTY. WE WERE INSTRUCTED BY COMPANY REP WITH STERIS TO DISPOSE OF ALL LOTS PRIOR TO 562488, AS THESE LOTS WERE HAVING THE ISSUE WITH THE SUCTION BUTTONS STICKING. THE FOLLOWING LOTS WERE FOUND PULLED AND DISCARDED AT (B)(6). 100EA X LOT 554141, 100EA X LOT 558615, 100 EA X LOT 549623, 9 EA X LOT 519959, 10 EA X LOT 524635, 49 EA X LOT 531790, 9 EA X LOT 543902, 5 EA X LOT 497403. MANUFACTURER RESPONSE FOR A/W/SUCTION AND BIOPSY KIT - ONE-TIME USE BUTTONS, DEFENDO A/W/SUCTION AND BIOPSY KIT (PER SITE REPORTER). WE WERE INSTRUCTED BY OUR REP WITH STERIS TO DISPOSE OF ALL LOTS PRIOR TO 562488, AS THESE LOTS WERE HAVING THE ISSUE WITH THE SUCTION BUTTONS STICKING. THE FOLLOWING LOTS WERE FOUND PULLED AND DISCARDED AT (B)(6). 100EA X LOT 554141, 100EA X LOT 558615, 100 EA X LOT 549623, 9 EA X LOT 519959, 10 EA X LOT 524635, 49 EA X LOT 531790, 9 EA X LOT 543902, 5 EA X LOT 497403.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902222 DEFENDO A/W/SUCTION AND BIOPSY KIT ENDOSCOPE CHANNEL ACCESSORY ODC MEDIVATORS INC. 100316 558615, 554141, 549623, 519959

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown