BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CUTTER STAPLER

    MDR report key: 3955540 · Received July 24, 2014

    Report

    Report Number
    3005075853-2014-05195
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS SHOWED THAT THE CS40G DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED VOID OF STAPLES, WITH THE WASHER COMPLETELY CUT, WITH THE DRIVERS EXPOSED AND WITH THE KNIFE RECESS BELOW THE CARTRIDGE DECK. IN ADDITION ANOTHER CARTRIDGE WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH AN ENGINEERING SAMPLE RELOAD AND THE DEVICE FIRED, FORMING ALL STAPLES AND CUTTING AS INTENDED. THE CUT LINE WAS COMPLETE, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE LOCKOUT AND THE RELOAD LOCKOUT WERE FUNCTIONAL. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION: WHAT DISEASE DID THE PATIENT HAVE? RECTAL CANCER. WAS RECTUM RESECTION HIGH OR LOW? LOW. HOW WAS THE OPERATION COMPLETED?COLOSTOMY. WHAT DID THE STAPLE FORM LOOK LIKE? THE FIRST RELOAD DIDN'T CUT AND DIDN'T EJECT THE CLIPS. THE SECOND ONE SUTURED CORRECTLY THE PROXIMAL SIDE , ON THE LOWER SIDE THE DEVICE DIDN'T EJECT THE CLIPS.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WE DON¿T KNOW WHERE IS THE LINK BETWEEN THE MALFUNCTION OF THE CS40G AND THE HOSPITALIZATION AND THE REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE OF THE PATIENT (THE PATIENT PROBABLY NEEDS A NEW INTERVENTION)? "FOLLOWING THE DEVICE¿S MALFUNCTION, THE PATIENT WAS SUBJECTED TO A COLOSTOMY." IF THE DEVICE JUST EXPELLED THE STAPLES WITHOUT CUTTING, WHAT WAS THE CAUSE OF THE COLOSTOMY? THE SURGEON USED TWO RELOADS AND FIRED TWICE: THE FIRST TIME THE DEVICE JUST EXPELLED THE STAPLES WITHOUT CUTTING, THE SECOND TIME (USING THE SECOND RELOAD) THE DEVICE CUT AND PUT THE STAPLES ONLY ON ONE SIDE. AFTER THE SECOND FIRE THERE WASN¿T ENOUGH TISSUE TO DO THE ANASTOMOSIS. DID THE SURGEON TRY ANOTHER CONTOUR OR A NEW RELOAD BEFORE DOING THE STOMA? HE USED 2 RELOADS. WAS THE COLOSTOMY PLANNED BEFOREHAND? NO IT WASN¿T. IS THE STOMA PERMANENT? NO. 5)WHO FIRED THE DEVICE, THE SURGEON OR SOMEONE ELSE? ANOTHER SURGEON, DR (B)(6). WAS THE USER TRAINED? YES HE WAS 7) HOW OFTEN HAS THIS PERSON USED THE DEVICE? HE USES THIS DEVICE DURING EVERY LOW ANTERIOR RESECTION (LAR) PROCEDURES. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 3RD, ETC)? ON THE FIRST AND ON THE SECOND. IF NOT THE FIRST FIRING, WERE THERE ANY PROBLEMS RELOADING THE DEVICE? PLEASE EXPLAIN. NO, "THERE WERE ANY PROBLEM." AFTER THE CLOSURE TRIGGER WAS ADVANCED, DID THE SURGEON REPOSITION THE TISSUE? YES HE DID. DID THE SURGEON INADVERTENTLY GRASP THE FIRING TRIGGER PRIOR TO FIRING THE INSTRUMENT? NO. WAS THE CLOSURE TRIGGER LATCHED PRIOR TO FIRING THE DEVICE? YES IT WAS. WAS THE SURGEON ABLE TO CONFIRM THAT THE INTENDED TISSUE WAS IN THE CLOSED JAWS OF THE INSTRUMENT PRIOR TO FIRING? YES. WAS THE TISSUE EVENLY DISTRIBUTED WITHIN THE JAWS OF THE INSTRUMENT? YES. WHAT WAS THE PATIENT¿S PRE-OP DIAGNOSIS? RECTAL CANCER. PLEASE PROVIDE THE PATIENT¿S SEX, AGE AND WEIGHT. MALE, (B)(6). WHAT IS THE CURRENT STATUS OF THE PATIENT? GOOD HEALTH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RECTUM RESECTION PROCEDURE, THE DEVICE EJECTED THE CLIPS PARTIALLY AND IT DID NOT CUT OR SUTURE. IT IS NOT KNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT REQUIRED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433851 CONTOUR CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR RELOAD - CR40G