BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 3000 60MM LONG

    MDR report key: 17661042 · Received August 31, 2023

    Report

    Report Number
    3005075853-2023-06297
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    January 10, 2023
    Report Date
    November 3, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036034988
    PMA / PMN Number
    K213633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/3/2023. D4: BATCH # 323C51. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON ENDO-SURGERY FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE ECH60L DEVICE WAS RETURNED WITH NO APPARENT DAMAGE AND WITH TEN GST60B RELOADS. THE RELOADS WERE RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES MEET THE STAPLE RELEASE CRITERIA. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 323C51, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. NO VIDEO OR PICTURES ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/27/2023.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/31/2023. D4: BATCH # UNK. B3: EXACT EVENT DATE UNKNOWN, ONLY DAY AND YEAR PROVIDED, ENTERED AS (B)(6) 2023. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT/BATCH NUMBER, A9CL76, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT ACTIONS WERE TAKEN TO CORRECT THE OBSERVED ISSUE? THE SURGEON TRANSECTED THE GASTRO-J ANASTOMOSIS AND CREATED A NEW ONE. DOES THE PROVIDER ATTRIBUTE THE EVENT PROBLEM TO STAPLE LINE OR STAPLE MALFORMATION? HE ATTRIBUTED THE EVENT TO THE STAPLE LINE, BUT NO MENTION OF MALFORMED STAPLES BY THE SURGEON PLEASE CLARIFY WHY 2 DEVICES ARE BEING RETURNED? TWO DEVICES TO INCLUDE ONE ECH60L. SECOND PRODUCT CODES IS THE STAPLE CARTRIDGE GST60B. SEVERAL WERE SENT BACK AS THE ONE USED DURING THE FIRING IN QUESTIONED COULD NOT BE IDENTIFIED. WAS THERE ANY OTHER ISSUE NOTED WITH THE STAPLE LINE OTHER THAN THE LEAK (MALFORMED STAPLES, STAPLE LINE MISSING STAPLES, ETC.)? SURGEON DID NOT COMMUNICATE ANY VISIBLE AND OR OBSERVED STAPLE LINE MALFORMATION. HOW WAS THE LEAK CONTROLLED? AFTER THE REVISING THE GJ THE LEAK TEST WAS PERFORMED AND NO BUBBLES WHERE IDENTIFIED RESULTING IN A REPAIR OF THE LEAK WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? (EXTENDED HOSPITAL STAY, READMISSION, RE-OPERATION, ETC.) A JP DRAIN WAS ORDERED WHICH IS NOT A CONSISTENT PRACTICE DURING A STANDARD GASTRIC BYPASS WHAT IS THE MOST CURRENT PATIENT HEALTH STATUS AND CONDITION? AS OF (B)(6) 2023 VIA A MOBILE TEXT THE SURGEON STATED, ¿JUST SAW HER IN THE OFFICE. DOING VERY WELL. THANKS. ¿ THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 · 0

    IT WAS REPORTED THAT DURING THE LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, AFTER THE CREATION OF THE G.J. ANASTOMOSIS, SURGEON COMPLETED LEAK TEST AND BUBBLES WERE IDENTIFIED AT THE POSTERIOR WALL OF THE STOMACH ON THE STAPLE LINE. IT WAS THE SEVENTH FIRE OF THE GUN. NO BUTTRESS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438245 ECHELON 3000 60MM LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. A9CL76 10705036034988

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GST60B| GST60B