BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED 60 ECHELON +, 440MM SHAFT

    MDR report key: 12532378 · Received September 27, 2021

    Report

    Report Number
    3005075853-2021-05745
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    January 1, 2021
    Report Date
    September 1, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014614
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/5/2021. ADDITIONAL INFORMATION : AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING DOCUMENTATION COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. IF THE PRODUCT OR ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED. 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. 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. WAS ANY SURGICAL INTERVENTION REQUIRED FOR THOSE THE CASE? I WAS TOLD THAT HE PUT THEM NPO WITH TPN. THE PATIENT HAD STENTS FOR A CERTAIN AMOUNT OF TIME FOLLOWED UP WITH TPN NPO. COULD YOU PLEASE CLARIFY IF WAS ANY CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? STENTS FOR A TIME FOLLOWED UP WITH TPN NPO. COULD YOU PLEASE CLARIFY WHAT IS THEIR CURRENT PATIENT STATUS? WILL HAVE TO CONFIRM WITH SURGEON: THE CURRENT PATIENT, HE THINKS MAY HAVE HEMATOMA INSTEAD OF LEAK. HE IS GOING TO LOOK TODAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY THE PATIENT DEVELOPED A LEAK. THE PATIENT RECEIVED A STINT. THERE IS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431967 POWERED 60 ECHELON +, 440MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PLEE60A 10705036014614

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown