BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DORSEY FENESTRATED GRASPER 25MM JAW ESU

    MDR report key: 8249960 · Received January 15, 2019

    Report

    Report Number
    1923569-2018-00026
    Event Type
    Injury
    Date Received
    January 15, 2019
    Date of Event
    December 25, 2018
    Report Date
    February 6, 2019
    Manufacturer
    CAREFUSION, INC
    Product Code
    GEI
    PMA / PMN Number
    K930666
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    731653: DEVICE MANUFACTURE DATE: SEPTEMBER 2018. UPON RECEIPT THE SAMPLE RECEIVED A VISUAL INSPECTION AND A FUNCTIONAL CHECK. THE FOLLOWING MARKINGS WERE FOUND ON THE DEVICE; SNOWDEN PENCER, I18, 90-6378, CE0123, AND A UDI MARK. NO EVIDENCE WAS FOUND THAT THE DEVICE IS NOT AUTHENTIC. UPON VISUAL INSPECTION IT WAS IDENTIFIED THAT THE PIN THAT JOINS THE ACTUATING ROD TO THE LINKS (92-0766), ONE LINK (94-0323), AND ONE RIVET (92-0752) WERE MISSING FROM THE DEVICE. A SCREW WAS NOT MISSING FROM THE DEVICE, BASED ON THE ITEMS MISSING, THE ITEM THAT WAS IDENTIFIED BY THE CUSTOMER AS A SCREW WAS PROBABLY THE RIVET, AS THE RIVET WOULD HAVE HAD AT LEAST ONE CHAMFERED END, LIKE SOME TYPES OF SCREWS DO. THIS CONFIRMS FAILURE OF TWO JOINTS, THE PIN/ACTUATING ROD/LINKS JOINT, AND THE JAW/RIVET/LINK JOINT. THE CLEVIS SCREW WAS REMOVED FROM THE DEVICE SO THE REMAINING COMPONENTS AT THE DISTAL END COULD BE MEASURED AROUND THE JOINTS THAT FAILED. HOLE SIZE AND COMPONENT THICKNESS AROUND THE JOINTS THAT FAILED WERE MEASURED ON THE COMPONENTS WHICH WERE RETURNED. THE ACTUATING ROD HOLE AND THICKNESS WERE FOUND TO BE CONFORMING TO PRINTS. THE LINK WAS FOUND TO CONFORM IN PIN HOLE SIZE AND PIN HOLE THICKNESS, BUT WAS FOUND TO BE UNDERSIZED IN RIVET HOLE THICKNESS PER PRINT, FROM WHICH COMPONENT 94-0323 ORIGINATES. ON THE JAW WITHOUT A LINK AND RIVET ATTACHED, THE RIVET HOLE WAS CONFORMING HOWEVER THE THICKNESS OF THE HOLE WAS UNDERSIZED. ON THE JAW WITH A LINK AND RIVET STILL ATTACHED, THE THICKNESS OF THE HOLE WAS FOUND TO BE UNDERSIZED. ADDITIONAL DISASSEMBLY OF THE COMPONENTS AT THE DISTAL END OF THE DEVICE COULD NOT BE PERFORMED WITHOUT ALTERING THE STATE OF THE COMPONENTS. ADDITIONALLY, BOTH SIDES OF THE CLEVIS, ON BOTH EDGES OF EACH SIDE, THERE IS DAMAGE TO THE CLEVIS EDGE FROM THE RIVETS DIGGING INTO THE CLEVIS. THIS DAMAGE OCCURS AS THE DEVICE IS CLOSED AND THE RIVETS ARE NOT FLUSH WITH THE LINKS AND JAWS, AND THE RIVET EDGE CATCHES ON THE CLEVIS EDGE. DURING ASSEMBLY A RIVET WITH ONE CHAMFERED HEAD JOINS THE LINKS TO THE JAWS, WITH EACH JOINED COMPONENT HAVING A RECESSED CHAMFER. THE CHAMFERED HEAD OF THE RIVET RESTS IN ONE RECESSED CHAMFER, AND THE OTHER END OF THE RIVET IS PEENED INTO THE OTHER RECESSED CHAMFER. AFTERWARDS, ANY EXCESS RIVET IS SHAPED DOWN TO BE FLUSH WITH THE LINK OR JAW. PHYSICAL EVIDENCE ON THE PARTS THAT WERE RETURNED INDICATES THAT THE OPERATOR SHAPED DOWN THE RIVET BEYOND BEING FLUSH WITH THE JAW/LINK SURFACE. THE CONSEQUENCE OF SHAPING DOWN BOTH THE RIVET AND THE LINK/JAW BEYOND FLUSH IS THAT IT REMOVES MATERIAL FROM BOTH THE CHAMFERED HEAD OF THE RIVET, AND THE CHAMFERED RECESS OF THE LINK/JAW. THE GREATER THIS LOSS IN MATERIAL THE EASIER IT BECOMES FOR THIS JOINT TO FAIL, AND THE RIVET TO EJECT FROM AXIAL MOVEMENT THROUGH THIS CYLINDRICAL JOINT. BECAUSE THE RIVET AND LINK BELONGING TO THE JAW/RIVET/LINK JOINT WERE NOT RETURNED, THERE IS NO PHYSICAL EVIDENCE OF THIS OCCURRING AT LINK/RIVET CHAMFER OF THIS JOINT. LOSS WAS OBSERVED ON THE JAW CHAMFER OF THE FAILED JOINT. THE SAME AMOUNT OF MATERIAL WAS LOSS FROM THIS CHAMFER ON THE JAW OF THE OTHER JAW/RIVET/LINK JOINT, HOWEVER THAT JOINT DID NOT FAIL. THE NON-CONFORMING JAW/RIVET/LINK JOINTS CONTRIBUTED TO THE DAMAGE PRESENT ON THE DEVICE, BECAUSE THE JOINTS WERE WEAKER, BUT THEY WERE NOT THE FIRST JOINT TO FAIL, AND WERE NOT DIRECTLY RELATED TO THE ROOT CAUSE. IF DURING THE INCIDENT THAT CAUSED THE COMPLAINT FAILURE MODE, THE RIVET HAD EJECTED FROM THE JOINT FIRST, THE PIN FROM THE OTHER JOINT WOULD HAVE REMAINED IN THE DEVICE, WITH THE LINK FROM THAT JOINT STILL ATTACHED TO THE PIN. THE PIN, THE ACTUATING ROD, AND LINKS ALL SLIDE IN UNISON BETWEEN THE TWO CLEVIS WALLS, AND THE PARALLEL PLANES OF THE LINKS, CLEVIS, AND ACTUATING ROD KEEP THEM ROTATING TOGETHER AS THE KNOB IS TURNED. IF THE RIVET HAD FAILED FIRST, THE USER WOULD NO LONGER USE THE DEVICE AS ONE JAW WOULD BE FLOPPING AROUND, AND THE LINKS/CLEVIS/ACTUATING RODS WOULD HAVE MAINTAINED THEIR PARALLELISM AND RETAINED THE PIN. THE PIN CAN ONLY COMPLETELY EJECT FROM THE DEVICE IF IT IS FRACTURED INTO PIECES, OR IF THE LINKS SEPARATE FROM THE PIN BY SLIDING OFF THE ENDS OF THE PIN, AND WITH NO MORE LINK SURFACES KEEPING THE ACTUATING ROD AND CLEVIS ROTATING TOGETHER, THE PIN GETS TURNED TOWARDS THE OPENINGS OF THE CLEVIS AND EJECTS. BECAUSE THE THICKNESS OF THE REMAINING LINK AT THIS JOINT AND THE ACTUATING ROD WERE FOUND TO BE CONFORMING, IT IS HIGHLY UNLIKELY THAT THE PIN AND LINK WERE NON-CONFORMING TO A SEVERE ENOUGH DEGREE TO ALLOW THE LINKS TO SLIP OF THE PIN, AND THE PIN TO TURN TOWARD THE OPENING. ALSO, ASSEMBLY DOES NOT REQUIRE THE PIN OR LINK AT THIS JOINT TO BE SHAPED DOWN. EVIDENCE OF A NONCONFORMANCE CAUSING SLIPPING CANNOT BE FOUND BECAUSE THE LINK AND PIN WERE NOT RETURNED WITH THE COMPLAINT SAMPLE. THE MOST LIKELY SCENARIO IS THAT THE DEVICE WAS SUBJECTED TO A SERIES OF MECHANICAL OVERSTRESSES THAT EVENTUALLY FRACTURED THE PIN, WHILE ALSO DEFORMING THE PEENED EDGE OF THE RIVETS, WHICH RESULTED IN THE PLAY BETWEEN THE CHAMFERED ENDS OF THE RIVET, AND THE CHAMFERED RECESSES OF THE LINKS/JAWS, ALLOWING THE RIVETS TO WOBBLE OFF AXIS DURING OPERATION AND CATCH ON THE CLEVIS EDGES. A SERIES OF MECHANICAL OVERSTRESSES WAS DETERMINED BY THE DAMAGE TO THE CLEVIS EDGES, HAD THE PIN AND RIVET ALL FAILED IN A SINGLE INCIDENT, THE ACTUATING ROD WOULD NOT HAVE BEEN ABLE TO PULL ON THESE COMPONENTS AND CAUSE THE RIVET EDGES TO DIG INTO THE CLEVIS. WHEN STRESS IS APPLIED TO METAL, IT CAN CAUSES RECOVERABLE DEFORMATION UNTIL A CERTAIN STRESS LEVEL IS REACHED, THEN AFTER THAT STRESS LEVEL IS EXCEEDED NON-RECOVERABLE DEFORMATION (DAMAGE) OCCURS TO THE METAL. DAMAGE TO THESE COMPONENTS OCCURRED OVER A SERIES OF MECHANICAL OVERSTRESSES. CUSTOMER IS ADVISED, DAMAGE TO THE COMPONENTS CAUSING FAILURE OF THE PEENED EDGES OF THE RIVET AND FRACTURING OF THE PIN CAN OCCUR EVEN WHEN ALL COMPONENTS ARE CONFORMING. IFU CF36-1831, FOR THIS DEVICE INSTRUCTS THE USER TO AVOID MECHANICAL SHOCK AND OVERSTRESS AS THIS MAY DAMAGE THE DEVICE. CUSTOMER SHOULD EXAMINE HOW THIS DEVICE WAS USED, AND HOW IT IS BEING HANDLED BY ALL PERSONNEL, INCLUDING PERSONNEL RELATED TO THE CLEANING, STERILIZATION, AND STORAGE OF THIS DEVICE, TO PREVENT DAMAGE THE COMPONENTS FROM BEING FURTHER DAMAGED BY MECHANICAL SHOCK AND OVERSTRESS. THE MOST PROBABLE ROOT CAUSE OF THE COMPLAINT FAILURE MODE IS MECHANICAL OVERSTRESS BY THE CUSTOMER, HOWEVER, EVIDENCE OF NON-CONFORMING COMPONENTS THAT CONTRIBUTED TO THE COMPLAINT FAILURE MODE WERE IDENTIFIED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND A CORRECTIVE ACTION PLAN HAS BEEN INITIATED FOR THE RIVETS/PEENING.

    Description of Event or Problem · 0

    THE SPD DIRECTOR, (B)(6), REPORTED THAT THERE WAS A RECENT INCIDENT WITH A SNOWDEN-PENCER LAPAROSCOPIC BOWEL GRASPER, ITEM #: SP90-6378 BREAKING DURING USE IN A PROCEDURE. HE SAID TOWARDS THE END OF A PROCEDURE A RESIDENT INSERTED THE INSTRUMENT, ATTEMPTED TO GRAB A SUTURE AND LOCK DOWN, AND WAS NOT ABLE TO COMPLETE THE TASK. AFTER A FEW ATTEMPTS, SHE PULLED THE INSTRUMENT OUT AND NOTICED THAT THE TIP WAS BROKEN (APPEARED TO BE MISSING A SCREW). THE INSTRUMENT WAS USED WITHOUT ISSUE FOR THE ENTIRE CASE PRIOR TO THAT TIME. THE MISSING SCREW WAS FOUND INSIDE THE PATIENT DURING THE SAME PROCEDURE AND THE PATIENT RECEIVED X-RAYS WHILE STILL IN THE OR. THERE WAS NO REPORTED ADVERSE EVENT CAUSING HARM TO THE PATIENT. THE PROCEDURE BEING PERFORMED WAS A LAPAROSCOPIC CHOLECYSTECTOMY.

    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 SPD DIRECTOR, (B)(6), REPORTED THAT THERE WAS A RECENT INCIDENT WITH A SNOWDEN-PENCER LAPAROSCOPIC BOWEL GRASPER - ITEM #SP90-6378 BREAKING DURING USE IN A PROCEDURE. HE SAID TOWARDS THE END OF A PROCEDURE A RESIDENT INSERTED THE INSTRUMENT, ATTEMPTED TO GRAB A SUTURE AND LOCK DOWN, AND WAS NOT ABLE TO COMPLETE THE TASK. AFTER A FEW ATTEMPTS, SHE PULLED THE INSTRUMENT OUT AND NOTICED THAT THE TIP WAS BROKEN (APPEARED TO BE MISSING A SCREW). THE INSTRUMENT WAS USED WITHOUT ISSUE FOR THE ENTIRE CASE PRIOR TO THAT TIME. THE MISSING SCREW WAS FOUND INSIDE THE PATIENT DURING THE SAME PROCEDURE AND THE PATIENT RECEIVED X-RAYS WHILE STILL IN THE OR. THERE WAS NO REPORTED ADVERSE EVENT CAUSING HARM TO THE PATIENT. THE PROCEDURE BEING PERFORMED WAS A LAPAROSCOPIC CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43070 DORSEY FENESTRATED GRASPER 25MM JAW ESU ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CAREFUSION, INC I18

    Patients

    Seq Age Sex Outcome Treatment
    1 Other