BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 2183031 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03077
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNCUT WASHER - BLEMISHED. (DEVICE B): SERIAL: (B)(4); OTHER # = G5ZW0F (BATCH #); EXP DATE = 06/09/2015, MFR DATE (DEVICE B): 7/9/2010. DEVICE A ARRIVED IN GOOD VISUAL CONDITION WITHOUT STAPLES PRESENT AND WITH THE BREAKAWAY WASHER UNCUT, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE. IT SHOULD BE NOTED THAT IF THE INDICATOR IS NOT FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE OR THE FIRING SEQUENCE IS NOT COMPLETE (PLASTIC TO PLASTIC), STAPLES COULD BE DEPLOYED WITHOUT COMPLETELY FORMING AND WITHOUT CUTTING THE WASHER. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR, THE DEVICE WILL NOT TRANSECT THE TISSUE COMPLETELY RESULTING IN DIFFICULTIES TO REMOVE THE DEVICE. FOR MORE INFORMATION, PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY; THE DEVICE FORMED ALL THE STAPLES, AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. DEVICE B ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT WHEN REMOVING THE DEVICE, OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. FOR EASY REMOVAL, ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS. TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90 DEGREES IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION NEEDED. IN ADDITION, PLEASE NOTE THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: WAS THE PROCEDURE DONE OPEN/LAPAROSCOPICALLY? OPEN , SCROTUM WAS THE SIZE OF A DOUBLE WATERMELON. WHAT DEVICE WAS USED FOR THE PROXIMAL TLC75 AND DISTAL TLC75 TRANSECTION? WHAT COLOR RELOAD? BLUE AND GREEN. WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE IN HIS/HER LEFT COLON PROCEDURES? PURSE STRING DEVICE COVIDIEN TIMES 3 HAD TO CUT OUT THE 1ST PURSE STRING, 2ND SUTURE BROKE AND UNKNOWN IF PURSE STRING LINE WAS CUT OUT BEFORE FIRING THE CDH29. WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? ASKU. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? CLICK. WHEN THE DEVICE WAS FIRED, WHERE WAS THE INDICATOR WITHIN THE GREEN ZONE/GAP SETTING SCALE? DIALED DOWN TIGHT AND HARD. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES. HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? CRUNCH. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES. IF YES, HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE? ABOUT ¾ AND OPENED MORE. WHAT STEPS WERE TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS? VISUALLY, THE DONUTS ARE IN THE DEVICE. DID THE OPERATION CHANGE SIGNIFICANTLY AS A RESULT OF THE DEVICE ISSUE? NO. WHAT IS THE PATIENT'S AGE AND SEX? MALE (B)(6), HTN, SEVERAL DISEASES. DID A HCP OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? YES. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INGUINAL HERNIA WITH BOWEL RESECTION PROCEDURE, THE SURGEON WAS UNSURE OF WHAT SIZE DEVICE TO USE. THE ANVIL OF A 33 DEVICE WAS PLACED IN THE SIGMOID THEN THE SURGEON TRIED THE DIFFERENT SIZERS AND THE 29 SEEMED TIGHT. THE SIZER FIT IN THE PROXIMAL END AND THE 33 ANVIL WAS REMOVED. THE FIRST PURSE STRING HAD TO BE CUT OUT AND ANOTHER PURSE STRING WAS PLACED BOTH WERE COVIDIEN PURSE STRING DEVICES AND THE SUTURE BROKE FROM THE SECOND PURSE STRING. A THIRD PURSE STRING DEVICE WAS USED THEN THE CDH29 WAS FIRED AND THERE WAS AN INCOMPLETE STAPLE LINE THEN THE DEVICE WAS STUCK AND DIFFICULT TO REMOVE. THE ANASTOMOSIS WAS COMPLETED BY HAND AND THE PROCEDURE WAS PROLONGED BY 30- 40 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1