BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEFANT SUCTION-IRRIGATION DEVICE

    MDR report key: 22852520 · Received August 20, 2025

    Report

    Report Number
    9610711-2025-00142
    Event Type
    Malfunction
    Date Received
    August 20, 2025
    Date of Event
    July 28, 2025
    Report Date
    December 15, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    FQH
    UDI-DI
    03600040970799
    Removal / Correction Number
    FSCA_2025008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW -UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION. B3: ESTIMATED DATE.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINTS AND WE FOUND OTHER COMPLAINTS REGARDING THE LOT NUMBER. THIS PRODUCT WAS MADE AT OUR MANUFACTURING PLANT IN HUNGARY WHICH WAS INFORMED ABOUT THIS ISSUE. THIS LOT IS PART OF A FOREIGN FIELD SAFETY NOTICE INITIATED IN AUGUST 2025. THE INVESTIGATION SHOWED THAT THE BITUBES INSIDE THE HANDLE WERE COLLAPSED. THIS COLLAPSING DOESN'T ALLOW SUCTION OR IRRIGATION, SO THE ELEFANT IS NON-FUNCTIONAL. A CORRECTIVE AND PREVENTIVE ACTION WAS OPENED IN AUGUST 2025 TO MANAGE THIS ISSUE. THE ROOT CAUSE HAS BEEN IDENTIFIED: THE RING PROTECTOR AROUND THE HANDLE WAS NOT CORRECTLY PLACED ON THE ELEFANT BUTTONS, AND THE ACTIONS ARE ONGOING. A CLINICAL ASSESSMENT WAS PERFORMED AND CONCLUDES: THE MALFUNCTION OF THE ELEFANT SUCTION¿IRRIGATION DEVICE, CAUSED BY A MISPLACED HANDLE PROTECTION CAP, RESULTS IN A COMPLETE LOSS OF SUCTION AND IRRIGATION FUNCTIONALITY. AS STATED IN THE INSTRUCTIONS FOR USE, THE DEVICE MUST BE TESTED BEFORE USE, WHICH ALLOWS EARLY IDENTIFICATION OF THE ISSUE AND PREVENTS PATIENT CONTACT. IN MOST CASES, THE CLINICAL IMPACT IS LIMITED TO A PROLONGED PROCEDURE AND DEVICE REPLACEMENT, CORRESPONDING TO A SEVERITY LEVEL 2 RISK. HOWEVER, GIVEN THAT THE ENTIRE LOT APPEARS TO BE AFFECTED, IT CANNOT BE RULED OUT THAT A REPLACEMENT DEVICE WILL BE AVAILABLE IN THE UNIT, WHICH MAY RESULT IN PROCEDURE RESCHEDULING, INCREASING THE CLINICAL IMPACT TO SEVERITY LEVEL 3. NO STERILITY CONCERNS ARE IDENTIFIED, AS THE DEVICE TIP REMAINS PROPERLY STERILIZED AND ISOLATED FROM INTERNAL FLUID PATHWAYS.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE FOUND SIX COMPLAINTS REGARDING THE LOT NUMBER. THIS LOT IS PART OF THE FIELD SAFETY NOTIFICE FSCA_20250808_ELEFANT SUCTION INITIATED IN AUGUST 2025. THE INVESTIGATION SHOWED THAT THE BITUBES INSIDE THE HANDLE WERE COLLAPSED. THIS COLLAPSING DOESN'T ALLOW SUCTION OR IRRIGATION, SO THE ELEFANT IS NON FUNCTIONAL. A CAPA WAS OPENED IN AUGUST 2025 TO MANAGE THIS ISSUE. THE ROOT CAUSE HAS BEEN IDENTIFIED: THE RING PROTECTOR AROUND THE HANDLE WAS NOT CORRECTLY PLACED ON THE ELEFANT BUTTONS, AND THE ACTIONS ARE ONGOING. A RMF EVALUATION WAS PERFORMED BASED ON CRIQ206 - RISK IDENTIFIED 11405 ( HAZARDOUS SITUATION: NO IRRIGATION AND / OR SUCTION) THE CALCULATION FOR THE PRODUCT FAMILY HAS BEEN DONE ON THE 25 COMPLAINTS (ACCOUNTABLE AS 55) RECEIVED AND THE HIGHEST RISK (COMBINATION OF THE SEVERITY AND PROBABILITY OF RISK (P1 X P2), THE HIGHEST HARM IS CONSIDERED AS DELAYED INTERVENTION (NEED TO RESCHEDULE FOR LACK OF MEDICAL DEVICE) WITH A SEVERITY PARAMETER LEVEL 3. BASED ON THE ABOVE, WE CAN CONCLUDE THAT THE OVERALL RESIDUAL RISK ASSOCIATED WITH THE USE OF THE MEDICAL DEVICE WHEN WEIGHED AGAINST THE BENEFIT/RISK RATIO TO THE PATIENT / USER IS NOT ADEQUATELY OR INSUFFICIENTLY CONTROLLED. NECESSARY ACTIONS NEED TO BE TAKEN TO REVIEW THE RISK MITIGATIONS AND TO RESET THE RISK CRITERIA IN THE GREEN AREA. A CLINICAL ASSESSMENT WAS ALSO PERFORMED AND CONCLUDE: THE MALFUNCTION OF THE ELEFANT SUCTION¿IRRIGATION DEVICE, CAUSED BY A MISPLACED HANDLE PROTECTION CAP, RESULTS IN A COMPLETE LOSS OF SUCTION AND IRRIGATION FUNCTIONALITY. AS STATED IN THE INSTRUCTIONS FOR USE, THE DEVICE MUST BE TESTED BEFORE USE, WHICH ALLOWS EARLY IDENTIFICATION OF THE ISSUE AND PREVENTS PATIENT CONTACT. IN MOST CASES, THE CLINICAL IMPACT IS LIMITED TO A PROLONGED PROCEDURE AND DEVICE REPLACEMENT, CORRESPONDING TO A SEVERITY LEVEL 2 RISK. HOWEVER, GIVEN THAT THE ENTIRE LOT APPEARS TO BE AFFECTED, IT CANNOT BE RULED OUT THAT NO REPLACEMENT DEVICE WILL BE AVAILABLE IN THE UNIT, WHICH MAY RESULT IN PROCEDURE RESCHEDULING, INCREASING THE CLINICAL IMPACT TO SEVERITY LEVEL 3. NO STERILITY CONCERNS ARE IDENTIFIED, AS THE DEVICE TIP REMAINS PROPERLY STERILIZED AND ISOLATED FROM INTERNAL FLUID PATHWAYS. A SIMILAR CASE STUDY WAS PERFORMED BASED ON ELEFANT PRODUCT; DEFECT: NO FUNCTIONALITY BEFORE USE OVER LAST FOUR YEAR: 147 SIMILAR CASES WERE FOUND.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE BUTTONS FOR SUCTION AND RINSING ARE NOT WORKING.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE BUTTONS FOR SUCTION AND RINSING ARE NOT WORKING.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE BUTTONS FOR SUCTION AND RINSING ARE NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544391 ELEFANT SUCTION-IRRIGATION DEVICE SURGICAL IRRIGATION/ASPIRATION CANNULA, NON-ILLUMINATING, SINGLE-USE FQH COLOPLAST A/S 10361477_ASP1854002 03600040970799

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown