BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 2854550 · Received December 3, 2012

    Report

    Report Number
    3005075853-2012-05427
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROLASPE OF HEMORRHOIDS PROCEDURE, THE SURGEON SAYS THAT THE STAPLE LINE WAS NOT COMPLETE. THERE WERE NO PATIENT CONSEQUENCES. CASE COMPLETED MANUALLY WITH SUTURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1