BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3013195 · Received March 20, 2013

    Report

    Report Number
    3005075853-2013-01323
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE AFFILIATE. PREMATURE SLED MOVEMENT. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. HAS ADDITIONAL TISSUE TO BE CUT OUT? IF YES, PLEASE SPECIFY THE AMOUNT OF ADDITIONAL TISSUE IN CM OR WAS THIS TISSUE INTENDED TO BE CUT AWAY ANYWAY? ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? WHAT WAS THE QUALITY OF TISSUE IN THE AREA WHERE THE DEVICE WAS FIRED? WHAT WERE THE PATIENT'S PRE-OP DIAGNOSIS, DID HE/SHE SUFFERS FROM CANCER, MORBUS CROHN OR COLITIS ULCEROSA? IF APPLICABLE, DOES THE PATIENT HAVE A HISTORY OF RECEIVING RADIATION OR CHEMOTHERAPY OR A RELEVANT HISTORY OF SURGICAL TREATMENTS? IF SO, WHAT? ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? WAS IT USED ON THICK TISSUE? DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE "CLICK"? WHAT COLOR CARTRIDGE WAS BEING USED? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? WHAT IS THE AGE AND SEX OF THE PATIENT? WHAT IS THE CURRENT STATUS OF THE PATIENT? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THE ANALYSIS FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH THE MANUAL OVERRIDE DOOR OUT OF POSITION AND MISSING; HOWEVER, THE DEVICE HAD NOT BEEN BAILED OUT. THE KNIFE WAS NOT FULLY RETRACTED, THUS THE DEVICE WOULD NOT OPEN. AN ECR60B PARTIALLY FIRED 1/16 WAS LOADED IN THE DEVICE. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. PLEASE NOTE IF THE INSTRUMENT IS PARTIALLY FIRED, SLIDE THE KNIFE REVERSE SWITCH FORWARD TO RETURN THE KNIFE TO HOME POSITION. TO OPEN THE JAWS, SQUEEZE THE CLOSING TRIGGER, AND THEN SIMULTANEOUSLY PRESS THE ANVIL RELEASE SWITCH ON EITHER SIDE OF THE INSTRUMENT. WHILE PRESSURE IS STILL ON THE ANVIL RELEASE SWITCH, SLOWLY RELEASE THE CLOSING TRIGGER. IT SHOULD BE NOTED AFTER THE MANUAL OVERRIDE DOOR IS REMOVED ON, THE INSTRUMENT IS DISABLED AND CANNOT BE USED FOR ANY SUBSEQUENCE FIRINGS UNTIL THE DOOR IS INSTALLED AGAIN. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. THE DEVICE CLOSED AND OPENED AS INTENDED DURING TESTING. THE KNIFE REVERSE MECHANISM PERFORMED PROPERLY. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANTERIOR RESECTION PROCEDURE WHILE PERFORMING A RESECTION THE DEVICE FIRED THE FIRST TIME AS EXPECTED. UPON RELOADING AND ATTEMPTING A SECOND CUT AND STAPLE THE SURGEON SAID "THE DEVICE LOCKED AND I COULDN'T GET THE THING OFF. I HAD TRIED THE REVERSE KNIFE DIRECTION BUTTON, TRIED TO OPEN JAWS WITH THE RELEASE/JAW CLOSURE TRIGGER, NEITHER OF WHICH WORKED. THEN ONCE THESE FAILED I OPENED THE MANUAL RELEASE SWITCH TO WINCH THE BLADE BACK AND NOTHING HAPPENED. SO WE OPENED AN ETS45 AND HAD THIS "MANUAL" DEVICE READY TO GO AND APPLIED FORCE TO PULL THE STAPLER OF THE WHILE THE JAWS WERE SHUT. ALTHOUGH IT CAME AWAY SUCCESSFULLY ALLOWING TO QUICKLY SWOP THE MANUAL DEVICE IN TO SUCCESSFULLY COMPLETE THE STAPLE THERE WAS SOME TEARING TO THE BOWEL. I WAS, HOWEVER, THEN ABLE TO CARRY THE PROCEDURE ON AND SUCCESSFULLY COMPLETELY. PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116782 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4C85D

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR