BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX 60 ARTICULATING

    MDR report key: 17030445 · Received May 31, 2023

    Report

    Report Number
    3005075853-2023-03604
    Event Type
    Injury
    Date Received
    May 31, 2023
    Date of Event
    March 1, 2023
    Report Date
    May 31, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001706
    PMA / PMN Number
    K081146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 5/31/2023 D4: BATCH # UNK B3: UNKNOWN, ASSUMED 1ST DAY OF MONTH THAT THE EVENT TOOK PLACE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS THERE ANY ADVERSE PATIENT OUTCOME? IF YES, WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED? EXTENDED HOSPITALIZATION. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: WERE THE THIRD-PARTY STAPLERS (B. BRAUN) USED WITH THE ETHICON DEVICES DURING THE SAME SURGERY? HOW WAS THE BLEEDING ADDRESSED? WAS A TRANSFUSION REQUIRED? WHERE WAS THE LEAK IDENTIFIED DURING THE RE-OPERATION? HOW WAS THE LEAK ADDRESSED? CAN A DETAILED TIMELINE OF EVENTS LEADING UP TO THE ISSUE BE PROVIDED? WAS THERE AN ALLEGED DEFICIENCY WITH THE ETHICON STAPLER DEVICE? IF SO, WHAT? DOES THE SURGEON BELIEVE THE ETHICON STAPLER DEVICE CAUSED OR CONTRIBUTED TO THE COMPLICATIONS OR WERE THERE OTHER CONTRIBUTING PATIENT FACTORS? WHAT IS THE PATIENT'S CURRENT STATUS? 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 AN ANTERIOR LAPAROSCOPIC RECTUM SURGERY, AFTER THE STAGE OF THE RESECTION PROCEDURE, END-TO-END FUSION WAS PERFORMED USING JOHNSON¿S LINEAR STAPLER (ETHICON) AND B.BRAUN¿S CIRCULAR STAPLER. AFTER TREATMENT, THE PATIENT HAD A LEAK IN THE JOINTS, DESPITE PROPER RING CONTINUITY CHECK AND LEAK TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029709 FLEX 60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. EC60A 10705036001706

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H