BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPTOR GRASPER, SP, ERG TA

    MDR report key: 3230046 · Received July 16, 2013

    Report

    Report Number
    1038548-2013-00017
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    CAREFUSION
    Product Code
    GCJ
    PMA / PMN Number
    K991928
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. IF IT IS RECEIVED AND AN EVALUATION IS DONE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4):ONE (1) DEVICE WAS RECEIVED FOR EVALUATION FOR THE ¿WHOLE JAW CAME OFF THE METAL INSERT.¿ THE DEVICE WAS FROM A SET AND HAD A DATE CODE OF A13 WAS WHICH INDICATES THIS INSTRUMENT WAS MANUFACTURED JANUARY 2013. THE CUSTOMER FAILED SAMPLES SHOW A FRACTURE AT THE ROD FORK WHERE ONE SIDE IS COMPLETELY BROKEN OFF. CAREFUSION IS AWARE OF THIS REPORTED FAILURE AND MODIFICATIONS HAVE BEEN MADE TO THE HEAT TREATING PARAMETERS, MATERIAL HARDNESS VALUES AND IMPROVEMENTS TO THE ELECTRO-POLISHING/PASSIVATION PROCESSES. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT DID NOT INDICATE ANY NON-CON CONFORMANCES. A TREND ANALYSIS WAS CONDUCTED FOR THIS REPORTED FAILURE MODE AND PRODUCT CODE. PREVIOUS COMPLAINTS HAVE BEEN FILED UNDER THIS REPORTED PROBLEM. WE WILL CONTINUE TO MONITOR AND TREND FOR THE REPORTED FAILURE FOR THIS PRODUCT CODE. OUR RECORDS HAVE BEEN UPDATED TO AID IN ACTIVITIES SHOULD ANOTHER ISSUE BE REPORTED FOR THIS PRODUCT CODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRAUMATIC GRASPER BROKE DURING A CASE. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT DURING THE CASE AND THERE WAS NO HARM TO PATIENT. THE CASE WAS A LAP CHOLE AND IT WAS COMPLETED AS PLANNED. ADDITIONAL INFORMATION (B)(6) 2013, THE FACILITY CONTACT REPORTED THAT HE FEELS THE SURGEON IS APPLYING TO MUCH FORCE TO THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328688 RAPTOR GRASPER, SP, ERG TA LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION SP94-8365

    Patients

    Seq Age Sex Outcome Treatment
    1 Other