BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2830085 · Received November 13, 2012

    Report

    Report Number
    3005075853-2012-05129
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE PSE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH TWO CARTRIDGES RELOADS PRESENT. THE CARTRIDGES RELOADS WERE RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. PLEASE ENSURE THAT THE TISSUE LIES FLAT AND IS POSITIONED PROPERLY BETWEEN THE JAWS. ANY BUNCHING OF TISSUE ALONG THE RELOAD, PARTICULARLY IN THE CROTCH OF THE JAWS, MAY RESULT IN AN INCOMPLETE STAPLE LINE. PLEASE REFER THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. 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. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL FOLLOWUP: ON WHAT TISSUE TYPE WAS THE DEVICE USED? REGULAR/THICK AT WHAT LOCATION ON THE TISSUE? STOMACH. WAS IT USED ON THICK TISSUE? YES (THE 1ST AND 2ND FIRINGS WERE AT THE THICKEST PART OF THE STOMACH). DID THE SURGEON WAITED THE RECOMMENDED 15 SECONDS AFTER CLOSING AND BEFORE FIRING THE DEVICE? YES. WAS THE CARTRIDGE CORRECT INSERTED, DID THEY HEAR THE 'CLICK'? YES. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? 3RD. WHAT COLOR CARTRIDGE WAS BEING USED? GOLD. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? GOLD. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES. 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 USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. CAN YOU PLEASE DESCRIBE THE STAPLE FORMATION? VERY BAD STAPLE FORMATION. PLEASE DESCRIBE THE SOUND OF THE MOTOR? NORMAL. WAS AN ATTEMPT MADE TO COMPLETE THE CASE LAPAROSCOPICALLY? YES. HOW IS THE PATIENT CURRENTLY? WITH A FISTULA IN THE INTENSIVE CARE. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? UNKNOWN.

    Description of Event or Problem · 1

    FOLLOWUP FROM (B)(4) 2012 - THE PATIENT IS BETTER BUT STILL IN THE HOSPITAL. THE SURGEON EXPECTS HER A FULL RECOVERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, AT THE THIRD FIRE THE BLADE PUSHED THE TISSUE OUT OF THE JAWS AND CUT PART OF THE STOMACH WITHOUT STAPLING. THE HOLE CREATED IN THE STOMACH LEAD TO THE CONVERSION OF THE SURGERY TO OPEN, WITH BIGGER RISK OF INFECTION, ADDITIONAL RECOVER TIME FOR THE PATIENT AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4AT09

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention