BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 3070176 · Received April 22, 2013

    Report

    Report Number
    3005075853-2013-01883
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION UNAVAILABLE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED AND IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND UNCUT AND THE DEVICE WAS FULLY LOADED WITH STAPLES, INDICATING THAT THE DEVICE HAD NOT BEING FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED WASHER AND IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE FOR PROLAPSE AND HEMORRHOIDS, STAPLES OF 1/3 ROUND WERE FORMED, BUT OTHER STAPLES WERE NOT DEPLOYED AND THE TARGET TISSUE WAS NOT CUT. A PURSE-STRING SUTURE WAS REMAINING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE FIRING FORCE WAS LOWER THAN EXPECTED. THE STAPLES DID NOT FALL OUT AND DID NOT REMAIN INSIDE THE DEVICE. THE DOCTOR COMMENTED THAT THERE HAD BEEN DIFFICULTY IN SUTURING AND THE TARGET TISSUE MIGHT NOT HAVE BEEN CLAMPED PROPERLY. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171027 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CC39

    Patients

    Seq Age Sex Outcome Treatment
    1