BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD 25MM CURVED CIRCULAR, 18CM SHAFT

    MDR report key: 10953338 · Received December 5, 2020

    Report

    Report Number
    3005075853-2020-06427
    Event Type
    Injury
    Date Received
    December 5, 2020
    Date of Event
    November 10, 2020
    Report Date
    November 10, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036015376
    PMA / PMN Number
    K163523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/09/20230. ADDITIONAL INFORMATION RECEIVED: PATIENT WAS DISCHARGED AFTER THE CONSERVATIVE TREATMENT. DOCTOR WHO USED POWERED CIRCULAR DIDN¿T THINK THE CAUSE OF THE LEAK WAS ONLY RELATED TO THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN; CAPTURED AS AWARENESS DATE. BATCH # UNK. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED.  ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT WERE THE INDICATIONS FOR SURGERY? => NO FURTHER INFORMATION IS AVAILABLE. WHAT SURGICAL PROCEDURE WAS PERFORMED? => AN OPEN TOTAL GASTRECTOMY. DID THE PATIENT RECEIVE ANY PREOPERATIVE CHEMOTHERAPY OR RADIATION? => NO FURTHER INFORMATION IS AVAILABLE. DOES THE SURGEON BELIEVE THAT THERE WAS AN ALLEGED DEFICIENCY OF THE CDH25P DEVICE THAT CAUSE OR CONTRIBUTED TO THE EVENTS THAT WERE REPORTED OR WERE THERE OTHER CONTRIBUTING FACTORS? => NO FURTHER INFORMATION IS AVAILABLE. WHAT CONSERVATIVE TREATMENT DID THE PATIENT RECEIVE? => NO FURTHER INFORMATION IS AVAILABLE. WERE THERE ANY ISSUES EXPERIENCED WITH THE DEVICE IN THE INITIAL SURGICAL PROCEDURE? => NO FURTHER INFORMATION IS AVAILABLE. WHAT HEALTHCARE PROFESSIONAL FIRED THE DEVICE AND WHAT IS HIS/HER EXPERIENCE WITH THE DEVICE? => NO FURTHER INFORMATION IS AVAILABLE. WHERE IN THE GREEN GAP SETTING SCALE WAS THE INDICATOR LOCATED PRIOR TO FIRING (LOW-B, MIDDLE-B, OR HIGH-B)? => NO FURTHER INFORMATION IS AVAILABLE. DID THE HEALTHCARE PROFESSIONAL WAIT 15 SECONDS AFTER CLOSING THE DEVICE AND THEN RETIGHTEN PRIOR TO FIRING? => NO FURTHER INFORMATION IS AVAILABLE. WERE THERE ANY ISSUES WITH DEVICE USE/FIRING? => NO FURTHER INFORMATION IS AVAILABLE. WHAT CONFIRMATION WAS RECEIVED THAT THE DEVICE COMPLETED THE FIRING SEQUENCE? => NO FURTHER INFORMATION IS AVAILABLE. WAS THE GREEN CHECKMARK VISIBLE AT THE END OF THE FIRING? => NO FURTHER INFORMATION IS AVAILABLE. HOW MANY COUNTER-CLOCKWISE REVOLUTIONS OF THE ADJUSTING KNOB WERE USED TO OPEN THE DEVICE? => NO FURTHER INFORMATION IS AVAILABLE. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE? => NO FURTHER INFORMATION IS AVAILABLE. WAS A COMPLETE TRANSECTION OF THE WHITE BREAKAWAY WASHER VISUALLY CONFIRMED? => NO FURTHER INFORMATION IS AVAILABLE. WERE THE DONUTS INSPECTED? => NO FURTHER INFORMATION IS AVAILABLE. IF SO, PLEASE DESCRIBE. WERE THERE ANY ISSUES NOTED WITH STAPLE FORMATION? => NO FURTHER INFORMATION IS AVAILABLE. IF SO, PLEASE DESCRIBE THE SHAPE AND LOCATION. WAS A LEAK TEST PERFORMED? => NO FURTHER INFORMATION IS AVAILABLE. IF SO, WHAT TYPE AND WHAT WAS THE RESULT? WAS THE STAPLE LINE VISUALIZED ENDOSCOPICALLY DURING THE INITIAL SURGICAL PROCEDURE? => NO FURTHER INFORMATION IS AVAILABLE. HOW MANY DAYS POSTOPERATIVE DID THE LEAK OCCUR? => NO FURTHER INFORMATION IS AVAILABLE. HOW WAS THE LEAK IDENTIFIED? WHAT WAS OBSERVED AT THE SITE OF THE LEAK UPON REOPERATION? => NO FURTHER INFORMATION IS AVAILABLE. HOW WAS THE LEAK ADDRESSED? => NO FURTHER INFORMATION IS AVAILABLE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FIELD AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN TOTAL GASTRECTOMY, LEAKAGE OCCURRED AFTER THE SURGERY. IT IS UNKNOWN HOW LEAKAGE WAS TREATED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418121 PWRD 25MM CURVED CIRCULAR, 18CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CDH25P T95921 10705036015376

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention