BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6329478 · Received February 14, 2017

    Report

    Report Number
    3005075853-2017-00917
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Date of Event
    February 7, 2017
    Report Date
    February 8, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND RECEIVED: THREE ECR60B RELOADS WERE REPORTED TO BE INVOLVED. DID THE ISSUE OCCUR WITH ONLY ONE OF THE THREE RELOADS BEING RETURNED FOR ANALYSIS? ISSUE OCCURRED WITH PROBABLY TWO OF THEM AS THE STAPLE LINE THAT STOOD OPENED WAS MORE THAN 6CMS AND WE DON¿T KNOW WHICH WERE THOSE TWO OUT OF THREE SO SENDING YOU ALL OF THEM. THREE INTRA-OPERATIVE PHOTOS WERE PROVIDED; ON THE THREE PHOTOS, TISSUE IS VISIBLE WITH WHAT APPEARS TO BE A PARTIAL STAPLE LINE. BASED ON THE PHOTO ALONE, THE EVENT DESCRIBE IS CONFIRMED, UNFORTUNATELY THERE IS NOT ENOUGH EVIDENCE IN THE PHOTO TO DETERMINE ROOT CAUSE. 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. 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. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH/LOT. ADDITIONAL INFORMATION REQUESTED BUT UNAVAILABLE: THREE ECR60B RELOADS WERE REPORTED TO BE INVOLVED. DID THE ISSUE OCCUR WITH ONLY ONE OF THE THREE RELOADS BEING RETURNED FOR ANALYSIS?

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THREE ECR60B CARTRIDGE RELOADS WERE RECEIVED. THE RELOADS WERE RECEIVED WITH NO APPARENT DAMAGE AND FULLY FIRED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE CASE WENT WELL BUT AS SOON AS THE SURGEON TOOK OUT SPECIMEN OF STOMACH HE FOUND THAT ON THE SPECIMEN SIDE THERE WAS NO STAPLE LINE NEAR TO THE FUNDUS AND THE STOMACH WAS TOTALLY OPENED; THIS WAS SURPRISING FOR ME AS WELL AS THE SURGEON. THE SURGEON THEN DID LEAK TEST WITH NORMAL SALINE AND THEN AGAIN WITH METHYLENE BLUE DYE BUT FORTUNATELY THERE WAS NO LEAK AND STAPLE LINE WAS INTACT, BUT SURPRISINGLY THERE WAS NO STAPLE LINE ON THE SPECIMEN SIDE. THE SURGEON ASKED FOR EVALUATION ON WHY THIS HAPPENED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113500 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK N4LV31

    Patients

    Seq Age Sex Outcome Treatment
    1 LONG60A