BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM CURVED

    MDR report key: 4153028 · Received October 8, 2014

    Report

    Report Number
    3005075853-2014-06845
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: WHEN WAS THE SAFETY RELEASED ON THE DEVICE? THE SURGEON RELEASED THE SAFETY RIGHT BEFORE FIRING AS USUAL. THE ANALYSIS RESULTS FOUND THAT THE CDH29A DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH NO STAPLES PRESENT. THE BREAKAWAY WASHER UNCUT AND INDENTED, 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 BEFORE FIRING THE DEVICE THE ORANGE INDICATOR SHOULD BE FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE. IN ADDITION IT SHOULD BE NOTED THAT IF THE FIRING SEQUENCE IS NOT COMPLETE (THE FIRING HANDLE REACHES ITS STOPPING POINT, AND THE FIRING TRIGGER IS PARALLEL TO THE INSTRUMENT HANDLE) 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 WITH A TEST WASHER; 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 THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE DEVICE IS RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION RECEIVED: THEY COULD NOT PERFORM AN ANASTOMOSIS SO THE SURGEON DID A COLOSTOMY ON THE PATIENT. AFFILIATE REFERENCE NUMBER: NONE PROVIDED OUR FIRST QUESTION IS IF THE DEVICE WILL BE RETURN? YES, IT WILL. TO GET MORE INFORMATION, BECAUSE THERE ARE TO LESS INFORMATION IN THE EVENT DESCRIPTION INCLUDED, WE HAVE SOME ADDITIONAL QUESTIONS: ON WHAT TISSUE TYPE WAS THE DEVICE USED? WHAT WAS THE QUALITY OF THE TISSUE? TISSUE WAS RECTUM AND COLON WITH NORMAL QUALITY. WAS THE DEVICE FIRED OVER THICK TISSUE? THE NORMAL THICKNESS OF RECTUM. DID THE SURGEON WAIT THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED TO THE TROCAR OF THE DEVICE? AUDIBLE CLICK. WHEN THE DEVICE WAS FIRED, WHAT WAS THE LOCATION OF THE INDICATOR WITHIN THE GAP SETTING SCALE (TOP/THIN, MIDDLE/MEDIUM, BOTTOM/THICK)? YES. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. HOW WAS IT CONFIRMED THAT THE DEVICE WAS FULLY FIRED (CRUNCH, LEVER COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? AUDIBLE CRUNCH. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER FIRING, DID THE FIRING HANDLE AUTOMATICALLY RETURN TO ITS ORIGINAL (PRE-FIRED) POSITION WITHOUT INTERVENTION? NO. WHAT PURSE STRING TECHNIQUE WAS USED OR WHAT PURSE STRING TECHNIQUE DOES THIS SURGEON NORMALLY USE? (EX. HAND TIED PURSE STRING, PURSE STRING DEVICE) PURSE STRING HAND HOW WAS THE PURSE STRING PLACED, BY HAND OR WITH AN ASSIST DEVICE? IF AN ASSIST DEVICE, WHAT PRODUCT? BY HAND. WAS THE SPIKE OF THE TROCAR INSERTED LATERAL OR THROUGH THE STAPLE LINE? NO. HOW THICK WAS THE TISSUE, WAS IT EVENLY AND TENSION-FREE DISTRIBUTED IN THE INSTRUMENT? 2.0 MM, YES. WAS THE ANVIL PUT ON THE TROCAR EXACTLY HORIZONTALLY? YES. PUTTING THE ANVIL ON THE TROCAR WERE ANY GRASPERS USED? NO. WAS THE DEVICE COMPLETELY FIRED PLASTIC TO PLASTIC? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IF YES, HOW MANY REVOLUTIONS OF THE ADJUSTING KNOB WERE USED TO OPEN THE DEVICE? NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE, PROCEDURE, PATIENT OR PHYSICIAN? NO. DID THE PATIENT GET A PERMANENT OR A TEMPORARY STOMA? PERMANENT STOMA. WHAT IS THE AGE AND SEX OF THE PATIENT? (B)(6), MALE. WHAT IS THE CURRENT STATUS OF THE PATIENT? STABLE BUT WITH A PERMANENT STOMA. I TALKED TO THE SURGEON TODAY AND SHE CONFIRMED SHE RELEASED THE SAFETY RIGHT BEFORE FIRING AS USUAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HARTMAN CLOSURE PROCEDURE THE CIRCULAR STAPLER CUT BUT APPARENTLY THERE WERE NO STAPLES ¿SO DID NOT STAPLE.¿ THEY COULD NOT PERFORM AN ANASTOMOSIS SO THE SURGEON DID A COLOSTOMY ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632150 ILS 29MM CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4E85R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention