BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 2822020 · Received October 3, 2012

    Report

    Report Number
    3004605321-2012-00001
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    June 15, 2011
    Report Date
    June 21, 2011
    Manufacturer
    DEROYAL INTERCONTINENTAL, S.L.R.
    Product Code
    HIF
    PMA / PMN Number
    K934131
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: THE HOSPITAL REPORTED THAT DURING LAPAROSCOPIC PROCEDURE THE ABDOMEN WOULD NOT INFLATE UNTIL THE FILTER WAS REMOVED. DEROYAL: IT WAS CONCLUDED THAT THE RESIN USED TO MANUFACTURE THE INSUFFLATION TUBING WAS INCOMPATIBLE WITH HEAT AND TIME VARIABLES THAT IT IS EXPOSED TO DURING SHIPMENT AND STERILIZATION. THIS CAUSES THE PLASTICIZER TO MIGRATE FROM THE TUBING TO THE FILTER HOUSING CAUSING OCCLUSION. MIGRATION RESISTANT MATERIAL, POLYCARBONATE, HAS BEEN CHOSEN AND SUCCESSFULLY TESTED FOR COMPATIBILITY OF EXPOSER TO HIGH HEAT. IN (B)(4) 2008, A 100% INSPECTION OF THE MODIFIED DEVICE WAS PERFORMED WITH NO DEFECTS FOUND.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING LAPAROSCOPIC PROCEDURE THE ABDOMEN WOULD NOT INFLATE UNTIL THE FILTER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL HIF- INSUFFLATOR, LAPAROSCOPIC HIF DEROYAL INTERCONTINENTAL, S.L.R. 21269906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other