BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATRAUMATIC FUNDUS GRASPING INSERTS

    MDR report key: 850454 · Received March 2, 2007

    Report

    Report Number
    2027111-2007-00012
    Event Type
    Other
    Date Received
    March 2, 2007
    Date of Event
    January 31, 2007
    Report Date
    February 26, 2007
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE 5MM BABCOCK INSERTS WERE RECEIVED FOR EVALUATION. ALL OF THE DOCUMENTS PERTAINING TO THE INSERTS AND THE SPECIFIC LOT WERE REVIEWED. THERE WERE NO ABNORMALITIES OR NON-CONFORMANCES THAT WERE NOTED IN THE DOCUMENTATION. AFTER PHYSICAL EXAMINATION OF THE INSERTS, IT WAS APPARENT THAT ONE OF THEM WAS IN FACT BROKEN. ONE OF THE LEGS ON THE INSERT THAT ATTACHES TO THE GRASPER APPEARED TO BE COMPLETELY SEVERED. AN ENGINEERING EVALUATION WAS PERFORMED TO REPLICATE THE FAILURE AND FOUND THAT A FORCE OF ROUGHLY 2.4 LBS WAS REQUIRED TO BREAK THE INSERT. THE INSERT IN ITS NORMAL INTENDED USE SHOULD NOT SEE ANYWHERE NEAR 2.4 LBS IN THE MANNER THAT WAS REQUIRED TO REPLICATE THE FAILURE. IT IS APPARENT THAT EXCESSIVE FORCE WAS APPLIED TO THE INSERT IN AN UNINTENDED WAY WHICH LED TO THE DESTRUCTION OF THE INSERT. ENGINEERING COULD REPRODUCE THIS TYPE OF FAILURE BY OVER STRESSING THE ATTACHMENT LEGS, ATTACHING THE INSERT TO A GRASPER, THEN PULLING THE GRASPER OUT THROUGH A CANNULA. THE INSERT COULD THEN BECOME CAUGHT ON THE EDGE OF THE CANNULA AND MORE THAN 2.4 LBS OF FORCE COULD BE APPLIED. INSERTS FROM THE SAME LOT (1022038) WERE PULLED AND INSPECTED. THEY WERE ATTACHED TO A 5MM A-TRAC GRASPER AND FUNCTIONED PROPERLY. THEY DID NOT SHOW ANY SIGNS OF FAILURE. THE COMPONENT BASE IS MOLDED USING GREY BARIUM POLYCARBONATE AND HAS PASSED RADIOPAQUE TESTING. CONCLUSION: THE C4103 5MM BABCOCK INSERTS WERE RECEIVED FOR EVALUATION AND ONE WAS FOUND TO BE DESTROYED. THE PROBABLE CAUSE OF THIS FAILURE IS EXCESSIVE FORCE APPLIED TO THE INSERT IN AN UNINTENDED MANNER. AN ENGINEERING ANALYSIS WAS PERFORMED AND SHOWED THAT THE FORCE REQUIRED TO REPLICATE THE FAILURE WAS FAR GREATER THAN FORCES THAT ARE EXPECTED ON THE INSERT THROUGH NORMAL USE.

    Description of Event or Problem · 1

    "ACCOUNT CALLED ME THIS A.M. REQUESTING SOMEONE FROM APPLIED SHOULD CONTACT THEM ASAP REGARDING REMOVAL OF DEVICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAUMATIC FUNDUS GRASPING INSERTS A-TRAC GRASPER INSERTS HET APPLIED MEDICAL RESOURCES C4103 1022038

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other