BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 4013076 · Received August 15, 2014

    Report

    Report Number
    3005075853-2014-05742
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF FURTHER DETAILS ARE RECEIVED AND/OR DEVICE IS RECEIVED AND ANALYZED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER CONFIRMED THAT THE CHARACTERISTIC CRACKING NOISE DURING FIRING OF THE DEVICE WAS NOT DETECTED. THE PATIENT IS FINE. THE DEVICE HAS BEEN DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, AFTER FIRING, THE DEVICE COULD NOT BE REMOVED AND HAD TO BE CUT OFF FROM THE TISSUE (DEVICE WAS JAMMED WITH THE TISSUE). THE SURGEON HAD TO GO ON WITH A PURSE STRING SUTURE AND ANASTOMOSE BY HAND. NO FURTHER DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490094 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4ER76

    Patients

    Seq Age Sex Outcome Treatment
    1