BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRASPER, WAVY SINGLE-ACTION, 45CM

    MDR report key: 6075743 · Received November 3, 2016

    Report

    Report Number
    1038548-2016-00098
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 20, 2016
    Report Date
    January 18, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    GCJ
    PMA / PMN Number
    K991928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ONE (1) SP8485 TA INSERT DEVICE WAS RETURNED FOR EVALUATION. VISUAL AND FUNCTIONAL EVALUATION BY THE PRODUCT ENGINEER AND THE QUALITY ENGINEER CONFIRMED THE REPORTED FAILURE. THE PRODUCT ENGINEER AND QUALITY ENGINEER REVIEWED THE RETURNED INSERT DEVICE AND VISUAL OBSERVATIONS REVEALED THAT THE JAW PART WAS SEPARATED FROM THE ACTUATING ROD. FURTHER EXAMINATION REVEALED THAT PART OF THE FORK ON THE ACTUATING ROD WAS BROKEN OFF / MISSING AND THE PIN THAT HOLDS THE JAW PART TO THE ACTUATING ROD WAS NOT RETURNED WITH THE BROKEN DEVICE. IT IS SUSPECTED THAT THE RETURNED DEVICE HAD A FRACTURE AT THE ROD FORK. THIS FAILURE WAS PREVIOUSLY IDENTIFIED IN THE TAKE APART LINE UNDER A DESIGN PROJECT AND COMPLETED WITH THE TAKE APART PRODUCT QUALITY IMPROVEMENT WHICH INCLUDES THE SINGLE ACTION ROD FAILURE. THERE WAS A CHANGE MADE TO STRENGTHEN THE ACTUATING ROD. AS PART OF DESIGN PROJECT, IMPROVEMENTS WERE MADE TO THE TAKE APART INSERTS ACTUATION ROD TO FURTHER DEFINE HEAT TREATMENT AND ELECTRO POLISH PARAMETERS THAT WOULD INCREASE STRENGTH OF MATERIAL PROPERTIES OF THE DEVICE. BASED ON THE INCOMING RECORDS FOR THIS DEVICE ACTUATING ROD, PART NUMBER 92-1363, LOT # 1213702G AND 12223001, THIS DEVICE WAS MADE PRIOR TO THIS DESIGN CHANGE AND THEREFORE MISSED THE IMPROVEMENTS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMANCES. THE DEVICE PASSED ALL ACCEPTANCE CRITERIA FOR RELEASE. CONCLUSION: CORRECTIVE AND PREVENTATIVE ACTION IDENTIFIED THE FOLLOWING PROBABLE ROOT CAUSES: AFTER EVALUATING THE QUALITY HISTORY RECORDS IT WAS OBSERVED THAT THE INCOMING INSPECTION LOTS WERE INCORRECTLY IDENTIFIED AS THE SAME LOT AND ACCEPTED WITHOUT INSPECTION. THE STRAIGHTNESS OF THE ROD FORK WAS NOT CLEARLY INDICATED ON THE PRINT. THE HEAT TREATMENT CYCLE WAS NOT ADEQUATELY SPECIFIED ON THE PRINTS WHICH LEAD TO UNFAVORABLE MATERIAL PROPERTIES (HARDNESS & BRITTLENESS). THE RAW MATERIAL STOCK WAS IDENTIFIED AS 420SS WITHOUT A RANGE OF CARBON TO FURTHER CHARACTERIZE THE MATERIAL WHICH COULD LEAD TO UNFAVORABLE MATERIAL PROPERTIES (BRITTLENESS). MECHANICAL OVERSTRESS IN THE USER ENVIRONMENT. BD WILL CONTINUE TO TREND AND MONITOR THIS REPORTED ISSUE AND FOR THIS PRODUCT FAMILY.

    Additional Manufacturer Narrative · 1

    (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE GRASPER HEAD BROKE OFF COMPLETELY INSIDE THE PATIENT DURING AN UNSPECIFIED ROBOTIC PROCEDURE. THE PART WAS RETRIEVED IMMEDIATELY WITH ANOTHER GRASPER WITHOUT THE NEED FOR AN X-RAY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTIONS NECESSARY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH ALL PARTS ACCOUNTED FOR AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728873 GRASPER, WAVY SINGLE-ACTION, 45CM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CAREFUSION, INC SP8485 863123 D14

    Patients

    Seq Age Sex Outcome Treatment
    1