BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G-PROX ENDOSCOPIC GRASPER

    MDR report key: 1071431 · Received July 9, 2008

    Report

    Report Number
    3004447686-2008-00002
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 9, 2008
    Manufacturer
    USGI MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K061276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FRICTION IN SYSTEM CONTRIBUTED TO FAILURE. TORQUE APPLIED BY USER AND PATIENT ANATOMY MAY HAVE INCREASED FRICTION. DEVICE DESCRIPTION: G-PROX ENDOSCOPIC GRASPER. REASON FOR DEVICE RETURN: DEVICE JAW LOCKUP DURING USE EVEN WITH HANDLE IN OPEN POSITION. ENGINEERING EVAL: THE DEVICE WAS EVALUATED IMMEDIATELY AFTER IT WENT THRU THE STANDARD CLEANING AND DISINFECTION PROCESS. THE DEVICE JAW LOCKUP WAS CONFIRMED. THE HANDLE WAS IN THE OPEN POSITION WITH THE JAW IN THE CLOSED POSITION. THE HANDLE WAS CLOSED AND OPEN SEVERAL TIMES TO FREE THE JAW BUT WITHOUT SUCCESS. WITH A PUSH OF THE LASERCUT TUBE PROXIMALLY ALLOWING IT TO RETRACT INSIDE THE MANIFOLD, THE JAW WAS ABLE TO BE OPENED. THE DEVICE JAW APPEARED TO BE IN GOOD WORKING CONDITION WITH TYPICAL WEAR. HOWEVER, THE DEVICE LENGTH WAS FOUND TO BE OUT OF SPECIFICATION BY .375" ON THE LONG SIDE. THE DEVICE WAS THEN OPENED AND CLOSED SEVERAL TIMES WITHOUT TISSUE IN THE JAW. NO LOCKUP WAS OBSERVED. THE DEVICE WAS THEN OPENED AND CLOSED WITH A SIMULATED TISSUE IN THE JAW. THIS TIME IT DID LOCKUP. THE LASERCUT TUBE AND MANIFOLD AREA WERE EXAMINED FOR SIGNS OF CATCHING THAT COULD BE THE CAUSE OF THE LOCKUP. FROM AN OUTSIDE VIEW OF THE MANIFOLD AREA, IT APPEARS THAT WHEN THE JAW HAS A BITE THE LASERCUT TUBE WILL KICK OVER ENOUGH TO RUB ON THE INSIDE EDGE OF THE MANIFOLD WITH ENOUGH TENSION THAT TO NOT FULLY RETRACT AND ALLOW THE JAW TO OPEN. WITH THE DRIVE TUBE DISCONNECTED FROM THE LASERCUT TUBE, IT WAS CONCLUDED THAT THERE ARE SEVERAL POSSIBILITIES FOR THE LASERCUT TUBE TO NOT FULLY RETRACT ALLOWING THE JAW TO OPEN. ONE POSSIBILITY IS THE CHAMFER EDGE ON THE INSIDE OF THE MANIFOLD CATCHING ON THE LASERCUT TUBE. THE SECOND POSSIBILITY IS THE STEP FROM THE DRIVE TUBE TO THE LASERCUT TUBE COLLAR BOND. THIS STEP COULD CATCH AND RUB ON THE TEFLON LINER BETWEEN THE DRIVE TUBE AND THE OUTER BODY. THE THIRD POSSIBILITY IS A COMBINATION OF BOTH POSSIBILITIES ONE AND TWO. ANOTHER LOCKUP CAUSE COULD BE RELATED TO DEVICE JAW GEOMETRY BEING OUT OF TOLERANCE DUE TO THE DEVICE LENGTH CHANGE. IT WAS LATER CONFIRMED THAT THE DEVICE LENGTH CHANGE IS CAUSED BY THE OUTER BODY STRETCHING. IT IS THE OPINION THAT THE LOCK-UP OF THE JAWS WAS A DIRECT RESULT OF A COMBINATION OF FACTORS, WHICH INCLUDE THE ABOVE OBSERVATIONS AS WELL AS THE STRETCHING OF THE SCOPE BODY. PROCESS AND DIMENSIONAL MODIFICATIONS TO REDUCE FRICTION WILL BE INVESTIGATED.

    Description of Event or Problem · 1

    A G-PROX ENDOSCOPIC GRASPER WAS INSERTED TRANS-ORALLY INTO THE STOMACH TO GRASP A FOLD OF STOMACH TISSUE. THE JAWS FAILED TO RELEASE THE TISSUE WHEN THE HANDLE WAS OPENED. THE PHYSICIAN APPLIED ROTATION AND RETRACTION FORCE AND WAS ABLE TO PULL THE CLOSED JAWS OFF OF THE TISSUE FOLD. VISUAL EXAMINATION OF THE TISSUE SHOWED MUCOSAL ABRASION. CONSERVATIVELY, THE PHYSICIAN ELECTED TO ADMIT THE PATIENT FOR OVERNIGHT OBSERVATION. A POST-PROCEDURE UPPER GI IMAGE CONFIRMED INTEGRITY OF THE GASTRIC TISSUE. THE PATIENT REQUIRED NO TREATMENT, REPORTED NO SYMPTOMS AND WAS DISCHARGED UNEVENTFULLY THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G-PROX ENDOSCOPIC GRASPER ENDOSCOPIC GRASPER GCJ USGI MEDICAL PME 080173

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization