BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH CIRCULAR STAPLER

    MDR report key: 6152810 · Received December 7, 2016

    Report

    Report Number
    3005075853-2016-06880
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    November 18, 2016
    Report Date
    November 23, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    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. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE: ECS29A. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WERE THE INDICATIONS FOR SURGERY: RECTUM TUMOR; WHO FIRED AND WHAT IS HIS/HER EXPERIENCE: THE SURGEON WHO IS EXPERIENCED; DID THE HEALTHCARE PROVIDER WHO FIRED THE DEVICE RECEIVE ANY AUDIBLE AND TACTILE FEEDBACK: YES; WAS THE FORCE TO FIRE HIGHER OR LOWER THAN EXPECTED: NORMAL; WERE THERE ANY ISSUES WITH STAPLE FORMATION, IF SO, PLEASE DESCRIBE THE SHAPE OF THE STAPLES: NO; WHERE IN THE GREEN RANGE WAS THE INDICATOR LOCATED PRIOR TO FIRING: HE CLOSED IN THE GREEN RANGE BELOW; WERE THE DONUTS INSPECTED, IF SO, PLEASE DESCRIBE: NO HE HAD TO MADE A LAPAROTOMY TO OPEN THE COLON BECAUSE OR CIRCULAR STAPLER WAS NOT COMING OUT; WAS THE WASHER INSPECTED, IF SO, PLEASE DESCRIBE: NO; HOW MANY COUNTERCLOCKWISE REVOLUTIONS WERE TAKEN TO REMOVE THE DEVICE: NONE; IS THE STOMA PERMANENT OR TEMPORARY: TEMPORARY.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS THE CURRENT PATIENT STATUS: STABLE, HE IS AT HOME ON THIS MOMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N55U3A. THE ANALYSIS RESULTS FOUND THAT THE ECS29A DEVICE ARRIVED WITH NO APPARENT DAMAGE. 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. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC RECTUM PROCEDURE, THE DEVICE COULDN'T BE REMOVED AFTER FIRING. THEY HAD TO REMOVE IT WITH FORCE AND THE PATIENT HAD TO BE CONVERTED AFTER THE PROCEDURE. PATIENT REQUIRED A STOMA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802982 ENDOPATH CIRCULAR STAPLER ENDOSCOPE AND/OR ACCESSORIES KOG ETHICON ENDO-SURGERY, LLC. NA N92D2E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention