BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORMIA NO-TIP / N-STONE

    MDR report key: 19563305 · Received June 18, 2024

    Report

    Report Number
    9610711-2024-00150
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    April 1, 2024
    Report Date
    October 7, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FFL
    UDI-DI
    03600040230053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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 DIDN'T FIND OTHER COMPLAINT ON THE LOT NUMBER 9020815. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. B3: ESTIMATED DATE.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT ON THE LOT N°9020815. WE RECEIVED TWO BASKET OF BROKEN DORMIA. AFTER DISINFECTION A VISUAL EXAMINATION WAS DONE AND BASKET SEEMS TO BE BROKEN OR CUT. THESE COMPONENTS WAS MADE BY OUR SUPPLIER WHICH WAS INFORMED ABOUT THIS ISSUE AND SAMPLES SENT FOR AN INVESTIGATION. ON JULY WE RECEIVED SUPPLIER'S CONCLUSION: THE REVIEW OF THE RELATED PRODUCTION DOCUMENTS DID NOT INDICATE ANY DEVIATIONS OR IRREGULARITIES. ALL PROCESS STEPS AND TESTS WERE CARRIED OUT IN ACCORDANCE WITH THE VALID DMR. DURING THE INVESTIGATION OF THE COMPLAINED PRODUCT, IT WAS FOUND THAT THE COREWIRE OF THE BASKET HAS BEEN CUT. AS THE FUNCTION AND THE TENSILE STRENGTH OF EACH BASKET IS 100% TESTED AT EPFLEX, WE ASSUME THAT THE DAMAGE IS DUE TO EXCESSIVE MECHANICAL LOAD. DUE TO THE 100% FUNCTIONAL TEST DURING PRODUCTION AT EPFLEX, WE CAN SAY WITH CERTAINTY THAT THE DAMAGE WAS NOT PRESENT AT THE TIME OF DELIVERY. IN ADDITION, OUR DOCUMENTATION REVEALS A 100% INSPECTION IS PERFORMED FOLLOWING OUR WORK INSTRUCTION ¿FSI¿ AND INSPECTIONS ARE DOCUMENTED ON PAGE 4 AND 5 /6 (SECTION 4 § 14): CONTROL REALIZED AT 100% AFTER THE ASSEMBLING : EACH STEP OF THE PROCESS. FUNCTIONALITY VERIFIED (SECTION 4). AFTER THE PACKAGING , VISUAL CONTROL AT 100%. DURING THE PACKAGING, A OPENING AND CLOSING TEST IS PERFORM THREE TIMES AND A CHECKING THE BASKET IS FULLY EXTENDED IS PERFORMED. ACCORDING TO THE INFORMATIONS KNOWN AND INVESTIGATION DONE, QUALITY DATABASES WAS CHECKED AND REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. A SIMILAR CASE STUDY WAS DONE BASED ON SAME ITEM NUMBER:EXT424; SAME DEFECT: BROKEN SINCE 4 YEARS AGO: ONE SIMILAR CASE WAS FOUND.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE BASKET BROKE AND REMAINED IN THE PATIENT. WHEN AN ATTEMPT WAS MADE TO EXTRACT THE BROKEN PROBE WITH ANOTHER PROBE, THAT PROBE BROKE ALSO.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE BASKET BROKE AND REMAINED IN THE PATIENT. WHEN AN ATTEMPT WAS MADE TO EXTRACT THE BROKEN PROBE WITH ANOTHER PROBE, THAT PROBE BROKE ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124495 DORMIA NO-TIP / N-STONE URINARY STONE RETRIEVAL BASKET, SINGLE USE FFL COLOPLAST A/S 9020815_EXT4241002 03600040230053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention