BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 2183042 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03085
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE 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. 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. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, 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)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: THE STAPLES WERE INCOMPLETE. THE PATIENT IS GOING BACK FOR SURGERY (B)(6) FOR A LEAKING ANASTAMOSIS RELATED TO THE FAILURE OF THE CONTOURED CURVED CUTTER. BLOOD LOSS IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYMPTOMS THAT THE PATIENT EXPERIENCED WAS A SPIKE IN TEMPERATURE, DISTENDED ABDOMEN AND NAUSEA. THE PATIENT RETURNED TO THEATRE (B)(6) AFTER THE INITIAL SURGERY DATE. THE APPEARANCE OF THE STAPLE LINE ON RE-OPERATION WAS INCOMPLETE, SOME STAPLES WERE OPEN. DURING THE RE-OPERATION, THE SURGEON HAD TO RE-SEW THE STAPLE LINE WITH SUTURE MATERIAL. BUTTRESS MATERIAL WAS NOT USED. THE INITIAL PROCEDURE WAS PROLONGED FOR APPROX 15-20 MINUTES. UNKNOWN HOW MUCH BLOOD LOSS THERE WAS. NO BLOOD TRANSFUSION REQUIRED. PATIENTS PRE-OP DIAGNOSIS CONFIDENTIAL. AGE AND SEX OF THE PATIENT CONFIDENTIAL. TISSUE QUALITY WAS NORMAL AS THE RESECTION WAS PERFORMED PAST THE AFFECTED AREA. THE PATIENT WAS SENT HOME, DATE UNKNOWN. NO FURTHER TREATMENT RELATING TO THE MISFIRE NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON FOUND IT DIFFICULT TO CLOSE THE COMPRESSION LEVER BEFORE FIRING. THE SURGEON TRIED TO TROUBLESHOOT BY REPLACING THE PRELOADED CARTRIDGE BY OPENING UP A NEW ONE AND RELOADING IT AGAIN. THIS TIME, HE WAS ABLE TO FULLY ENGAGE THE COMPRESSION LEVER AND THEN FIRED THE FIRING LEVEL PLASTIC TO PLASTIC. WHEN THE RELEASE BUTTON WAS DEPRESSED, THE DEVICE WAS REMOVED FROM THE PATIENT AND THE ROWS OF STAPLES WERE INCOMPLETE AND THE SURGEON WAS FORCED TO HAND SEW THE DISTAL PORTION OF THE BOWEL. THE SURGEON SEWED THE LEAKING TRANSECTED BOWEL RESULTING IN INCREASED PROCEDURE TIME AND INCREASE BLOOD LOSS. PATIENT IS UNDER MONITORING FOR A LEAKING ANASTAMOSIS AS A RESULT OF THE MISFIRE. SURGERY WAS PROLONGED 15 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2011, (B)(6) 2011 AND (B)(6) 2011 AND NO MORE INFORMATION HAS BEEN RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R RELOAD-(B)(4)