BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 2133509 · Received June 20, 2011

    Report

    Report Number
    3005075853-2011-02475
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = UNCUT WASHER - UNBLEMISHED ADDITIONAL INFORMATION: WAS THE PROCEDURE DONE OPEN/LAPAROSCOPICALLY? OPEN. WHAT DEVICE WAS USED FOR THE TRANSACTION? WHAT COLOR RELOAD? ATS BLUE LOAD. WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE IN HIS/HER LEFT COLON PROCEDURES? SIDE TO SIDE. HOW WAS THE PURSE STRING PLACED, BY HAND? BY HAND. WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? LATERAL. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? FELT ENGAGED AND SAW THE SPRINGS, DID NOT HEAR A CLICK. WHEN THE DEVICE WAS FIRED, WHERE WAS THE INDICATOR WITHIN THE GREEN ZONE/GAP SETTING SCALE? AT THE BOTTOM OF THE GREEN. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? THE DEVICE DID NOT GIVE CONFIRMATION B/C IT WAS NOT FULLY FIRED. 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? IF YES, HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE? NO. WHAT STEPS WERE TAKEN TO CONFIRM SUCCESSFUL ANASTOMOSIS? HAD TO USE NEW DEVICE TO CONFIRM ANASTOMOSIS. DID THE OPERATION CHANGE SIGNIFICANTLY AS A RESULT OF THE DEVICE ISSUE? PROLONGED THE PROCEDURE TO ABOUT 45 MINUTES. WHAT IS THE PATIENT'S AGE AND SEX? FEMALE (B)(6). DID A HCP OTHER THAN THE PRIMARY SURGEON FIRE THE INSTRUMENT? PRIMARY SURGEON. WAS THERE A RECENT CONVERSION TO EES DEVICES IN THIS ACCOUNT OR WITH THIS SURGEON? NO. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION, VOID OF STAPLES AND WITH THE BREAKAWAY WASHER UNCUT, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE, THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE OR THE ANVIL WAS NOT REATTACHED CORRECTLY. IT SHOULD BE NOTED THAT BEFORE FIRING, ENSURE THAT THE ORANGE INDICATOR IS FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE AND THE ANVIL IS REATTACHED CORRECTLY. TO REATTACH THE DETACHABLE HEAD OR ANVIL, DO NOT CLAMP ACROSS OR GRIP ON THE LOCKING SPRINGS AS IT MIGHT NOT CLICK INTO PLACE. NOT REATTACHING THE ANVIL CORRECTLY OR THE ORANGE INDICATOR NOT BEING SET ON THE GREEN RANGE WILL RESULT IN A BIGGER GAP BETWEEN THE ANVIL AND THE GUIDE FACE. THEREFORE, THE STAPLES WILL NOT HIT THE ANVIL TO MAKE B- FORMED STAPLES. IN ADDITION, IF THE FIRING SEQUENCE IS NOT COMPLETE, STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. 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. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVERSE COLOSTOMY PROCEDURE, WHEN THE DEVICE WAS FIRED, THERE WAS NO CRUNCH AND ONLY SOME OF THE STAPLES WERE DEPLOYED. THE DONUTS WERE NOT CHECKED. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA G4T32R

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR