BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEFANT SUCTION-IRRIGATION DEVICE

    MDR report key: 18539776 · Received January 18, 2024

    Report

    Report Number
    9610711-2024-00021
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    November 29, 2023
    Report Date
    July 30, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FQH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND NONE REGARDING THE LOT NUMBER 9111502. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN RELATION TO THE DESCRIBE DEFECT. A SIMILAR CASE STUDY WAS PERFORMED BASED ON SAME ITEM NUMBER ASP185, SAME DEFECT: BROKEN OVER LAST FOUR YEARS: NO SIMILAR CASE WAS FOUND. IN FEBRUARY, WE RECEIVED ONE USED SAMPLE. AFTER DISINFECTING, THE SAMPLE WAS RETURNED TO OUR MANUFACTURING SITE FOR ELEFANT IN HUNGARY. IN MAY, WE RECEIVED THE INVESTIGATION: "ACCORDING TO OUR INVESTIGATION WE COULDN'T FIND THE ROOT CAUSE IN OUR PRODUCTION." THE HUNGARIAN INVESTIGATION CONCLUDED: 1. INVESTIGATION FOUND THAT DURING PRODUCTION CANULE CANT TEAR OR BREAK. OPERATORS WERE MONITORED AND DURING PRODUCTION THEY FOLLOWED VV-0181382 V5.0. 2. IF CANULE ARRIVES ALREADY DAMAGED PRODUCTION SHOULD NOTICE IT DURING VISUAL INSPECTION ACCORDING TO VV-0181390 V2.0 WITH ENDOSCOPE AND VV-0181382 V5.0 VISUALLY. BOTH TEST WERE CONFORM IN CASE OF THIS LOT. 3. DURING PACKAGING OPERATORS DIDNT FOLLOW THE VV-0181384 V4.0 INSTRUCTIONS. MONITORING OF THE PACKAGING PROCESS FOUND THAT OPERATORS FOLLOW THE INSTRUCTIONS WELL. QA CHECK ON FINAL PACKAGING WAS OK ON THIS LOT. ACCORDING TO OUR INVESTIGATION THE CANULE WAS WHOLE AND WITHOUT TEAR WHEN WE SENT IT OUT FOR STERILIZATION.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE CANNULA BROKE IN TWO DURING THE INTERVENTION. THE ENTIRETY WAS ABLE TO BE RECOVERED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE CANNULA BROKE IN TWO DURING THE INTERVENTION. THE ENTIRETY WAS ABLE TO BE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421482 ELEFANT SUCTION-IRRIGATION DEVICE SURGICAL IRRIGATION/ASPIRATION CANNULA, NON-ILLUMINATING, SINGLE-USE FQH COLOPLAST A/S 9111502_ASP1851002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other