BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERED 60 ECHELON +, 440MM SHAFT

    MDR report key: 10968735 · Received December 8, 2020

    Report

    Report Number
    3005075853-2020-06492
    Event Type
    Death
    Date Received
    December 8, 2020
    Date of Event
    October 30, 2020
    Report Date
    November 10, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014614
    PMA / PMN Number
    K110385
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 2/10/2021. TWO VIDEOS RECEIVED. UPON VISUAL INSPECTION OF TWO VIDEOS, THE FOLLOWING WAS OBSERVED: THE FIRS VIDEO SHOWS AT THE 1:52 MARK A LEAK OF BODY FLUIDS WAS NOTED UNDER THE LIVER. HOWEVER, NO STAPLE LINE APPEARS TO BE OVER THIS AREA. AT THE 15:37 MARK A BUTTRESSING WITH STAPLES IN B-FORM WAS NOTED ON THE TISSUE AND A YELLOW FLUID STARTED TO COME OUT UNDER THE BUTTRESSING WITH STAPLES OBSERVED. THE SECOND VIDEO SHOWS SOME SURGICAL INSTRUMENT HANDLING TISSUE. AT THE 1:51 MARK A DEVICE IS INTRODUCED WITH A BLACK RELOAD LOADED, BUTTRESSING IS NOTED ON THE DECK AND ANVIL OF THE DEVICE. AT THE 2:16 MARK THE DEVICE IS PLACED ON THE TISSUE. AT THE 2:45 MARK THE DEVICE IS REMOVED OF TISSUE AND THE STAPLE LINE AND CUT LINE WERE AS EXPECTED. AT THE 3:26 MARK A DEVICE IS INTRODUCED WITH A GREEN RELOAD LOADED, BUTTRESSING IS NOTED ON THE DECK AND ANVIL OF THE DEVICE. AT THE 3:28 MARK THE DEVICE IS PLACED ON THE TISSUE. AT THE 4:11 MARK THE DEVICE IS REMOVED OF TISSUE AND THE STAPLE LINE AND CUT LINE WERE AS EXPECTED. AT THE 4:49 MARK A DEVICE IS INTRODUCED WITH A GREEN RELOAD LOADED, BUTTRESSING IS NOTED ON THE DECK AND ANVIL OF THE DEVICE. AT THE 5:20 MARK THE DEVICE IS PLACED ON THE TISSUE AND FIRED IN ARTICULATED POSITION. AT THE 6:07 MARK THE DEVICE IS REMOVED OF TISSUE AND THE STAPLE LINE AND CUT LINE WERE AS EXPECTED. AT THE 6:47 MARK A DEVICE IS INTRODUCED WITH A WHITE RELOAD LOADED, BUTTRESSING IS NOTED ON THE DECK AND ANVIL OF THE DEVICE. AT THE 7:12 MARK THE DEVICE IS PLACED ON THE TISSUE AND FIRED IN ARTICULATED POSITION. AT THE 7:42 MARK THE DEVICE IS REMOVED OF TISSUE AND THE STAPLE LINE AND CUT LINE WERE AS EXPECTED. AT THE 8:20 MARK SLIGHTLY BLEEDING WAS NOTED ON THE PREVIOUS STAPLE LINE. AT THE 8:23 MARK A DEVICE IS INTRODUCED WITH A WHITE RELOAD LOADED, BUTTRESSING IS NOTED ON THE DECK AND ANVIL OF THE DEVICE. AT THE 9:22 MARK THE DEVICE IS PLACED ON THE TISSUE. AT THE 9:51MARK THE DEVICE IS REMOVED OF TISSUE AND SLIGHTLY BLEEDING WAS NOTED ON THE STAPLE LINE. AT THE 11:04 MARK A DEVICE IS INTRODUCED WITH A WHITE RELOAD LOADED, BUTTRESSING IS NOTED ON THE DECK AND ANVIL OF THE DEVICE. AT THE 11:15 MARK THE DEVICE IS PLACED ON THE TISSUE AND FIRED IN ARTICULATED POSITION. AT THE 11:51 MARK THE DEVICE IS REMOVED OF TISSUE AND THE STAPLE LINE AND CUT LINE WERE AS EXPECTED. BASED ON THE VIDEOS REVIEWED, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, THE ASSIGNABLE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. 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-CONFORMANCE. ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT A PATIENT DEVELOPED A LEAK FROM A SLEEVE GASTRECTOMY PROCEDURE THAT WAS CONDUCTED ON 10/27. THE SURGERY ON 10/27 WENT AS PLANNED, AND THE SURGEON DID USE A SCOPE TO VISUALLY INSPECT THE STAPLE LINE. THE PATIENT WAS SENT HOME. 4 OR 5 DAYS LATER THE PATIENT WAS RETURNED TO THE OPERATING ROOM WITH A SUSPECTED LEAK. A LEAK RIGHT AT THE GE JUNCTION WAS IDENTIFIED DURING THE RE-OPERATION, HOWEVER, THE PATIENT CODED AND PASSED AWAY DURING THE PROCEDURE. IT WAS NOTED BY SURGEON THAT THE SLR MATERIAL SEEMED TO BE ¿STUCK TO EVERYTHING¿ AND MENTIONED THAT THERE SEEMED TO BE AN INFLAMMATORY REACTION, CAUSING SLR TO ADHERE TO NEARBY TISSUES. HE CONTINUES TO USE PLEE60A AND ECH60R. PRIOR TO CONVERTING FROM SEAM GUARD TO ECH60R A FEW MONTHS AGO, THE SURGEON WOULD USE 1 BLACK RELOAD AND GREEN RELOADS FOR THE REST OF THE FIRINGS IN HIS SLEEVES. WHEN THE SURGEON STARTED TO USE SLR, HE SWITCHED TO 1 BLACK, 2 GREENS, AND GOLD FOR THE REMAINDER OF THE FIRINGS. SINCE THIS ISSUE HE HAS STOPPED USING GOLD AND RETURNED TO GREEN FOR ALL FIRINGS EXCEPT FOR THE FIRST. THE REOPERATION WAS ON 10/30. NO ISSUES WITH STAPLE FORMATION WERE NOTED. CAUSE OF ARREST/ DEATH ARE UNKNOWN AT THIS TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SLEEVE GASTRECTOMY, PATIENT WENT HOME. AFTERWARDS PATIENT HAD A COMPLICATION LEAK. PATIENT RETURNED TO OPERATING ROOM. IN FOLLOW UP SURGERY, DISCOVERED PATIENT HAD A LEAK ON THE STAPLE LINE. PATIENT CODED DURING SURGERY AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429327 POWERED 60 ECHELON +, 440MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PLEE60A 10705036014614

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 1 PRODUCT INVOLVED| 1 PRODUCT INVOLVED| 1 PRODUCT INVOLVED| 7 PRODUCTS INVOLVED| 1 PRODUCT INVOLVED| 1 PRODUCT INVOLVED| 1 PRODUCT INVOLVED| 7 PRODUCTS INVOLVED