BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPTOR GRASPER

    MDR report key: 3850622 · Received June 5, 2014

    Report

    Report Number
    1038548-2014-00041
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CAREFUSION
    Product Code
    GCJ
    PMA / PMN Number
    K991928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ONE (1) SP8365 TA INSERT WAS RECEIVED FOR EVALUATION FOR FELL APART DURING SURGERY. THE GRASPER TIP SP8365 (B)(4) FELL APART INTO PIECES INSIDE OF THE PATIENT. ALL PARTS WERE ACCOUNTED FOR WITH THE EXCEPTION OF PIN #1 (PART NUMBER 92-1467). SEVERAL ATTEMPTS WERE MADE TO THE SALES REP AND THE CUSTOMER WHETHER THE PIN WAS RETRIEVED. NO INFORMATION WAS RECEIVED ON PIN#1. THE INSERT DEVICE WAS RETURNED WITH THE JAW PIECE SEPARATE FROM THE ROD. THEREFORE, QUALITY AND PRODUCT ENGINEERING CONDUCTED AN EVALUATION OF THE RETURNED INSERTS AND CONFIRMED THE REPORTED ISSUE. THE TA INSERT WAS MANUFACTURED AS PART OF SET SP94-8365 WITH A DATE CODE OF F13. IT WAS VERIFIED TO BE MANUFACTURED JUNE 12 2013 UNDER LOT# 856122. THE FAILED SAMPLES SHOWS A FRACTURE AT THE ROD FORK WHERE ON SIDE IS COMPLETELY BROKEN OFF. THIS FAILURE MODE WAS ANALYZED UNDER A CORRECTIVE ACTION AND ONE OF THE ROOT CAUSES WAS ATTRIBUTED TO OVERSTRESS. DESIGN CHANGES HAVE BEEN IMPLEMENTED TO MITIGATE THIS ISSUE BASED ON TRENDING AND WERE IMPLEMENTED AS OF JANUARY 2014. THIS ISSUE CONTINUES TO BE EVALUATED AND TRENDED TO ENSURE SIMILAR ISSUES ARE NOT PRESENT WITH THE NEWLY DESIGNED INSERT.

    Description of Event or Problem · 1

    BROKEN SP8365 - FELL APART DURING SURGERY:THIS COMPLAINT IS IN CONJUNCTION WITH (B)(4): ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 FROM THE SALES REP. THE INSTRUMENTS WERE USED AS A SET DURING AN UNKNOWN PROCEDURE. THE ACTUAL GRASPER TIP SP8365 (B)(4) FELL APART INTO PIECES INSIDE OF THE PATIENT. THE INSTRUMENT SET IS CURRENTLY WITH THE CUSTOMER'S RISK DEPARTMENT FOR THEIR OWN INVESTIGATION: ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP (B)(6) 2014. IT WAS REPORTED THAT THE CUSTOMER SPECULATES THAT THE ONLY PART NOT RETRIEVED FROM THE PATIENT IS PIN#1 BUT HAVE NOT YET DONE AN MRI TO CONFIRM THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329999 RAPTOR GRASPER LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION SP8365 846122 (PART OF SET SP94-8365)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other