BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 2012953 · Received March 10, 2011

    Report

    Report Number
    3005075853-2011-00960
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE IS BEING RETAINED BY LEGAL THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). WASHER UNCUT. THE ANALYSIS RESULTS FOUND THAT THE PPH03 DEVICE ARRIVED IN GOOD VISUAL CONDITION WITHOUT STAPLES PRESENT AND WITH THE BREAKAWAY WASHER UNCUT AND INDENTED, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE. IT SHOULD BE NOTED THAT BEFORE FIRING THE DEVICE, THE ORANGE INDICATOR SHOULD BE FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE. IN ADDITION, IT SHOULD BE NOTED THAT IF THE FIRING SEQUENCE IS NOT COMPLETE (PLASTIC TO PLASTIC), STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. FOR MORE INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY WITH A TEST WASHER; THE DEVICE 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. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MUCO-HEMORRHOIDAL PROLAPSE PROCEDURE, DURING THE CASE, AS USUAL THE SURGEON USED THE DEVICE IN ORDER TO APPLY STAPLES AND RESECTION THE TISSUE, BUT HE HASN`T HAD THE SENSATION THAT THE STAPLES WERE APPLIED ON THE TISSUE AND THE CONSEQUENT RESECTION. AS A CONSEQUENCE, THERE WAS A PARTIAL LACERATION OF THE RECTAL WALL. ON THE LACERATION WERE APPLIED MANUAL SUTURES. IT WASN`T POSSIBLE TO COMPLETE THE PLANNED CASE. IT WAS NECESSARY TO EXTEND PATIENT HOSPITALIZATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4T176

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization