BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGI 60 ARTICULATING MED/THICK SULU

    MDR report key: 3964060 · Received May 22, 2014

    Report

    Report Number
    1219930-2014-00388
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 30, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GAG
    PMA / PMN Number
    K083519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) ACCORDING TO THE REPORTER: THE SURGEON USED THE IDRIVE ULTRA. THE STAPLER WAS INSERTED INTO THE TROCAR INCORRECTLY BY THE SURGEON. THE SURGEON DID NOT INSERT THE STAPLER FULLY, CAUSING THE STAPLER LOAD POINT TO BREAK. THE ARTICULATION OF THE STAPLER WAS FUNCTIONING CORRECTLY BUT THE SURGEON PUSHED THE BLUE TOGGLE TOO QUICKLY. AS A RESULT THE LOAD POINT WAS BROKEN. THERE WAS NO PATIENT INJURY. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306634 EGI 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLER GAG COVIDIEN, FORMERLY US SUR N3H0208LX

    Patients

    Seq Age Sex Outcome Treatment
    1 IDRIVE ULTRA POWERED HANDLE 1,| IDRVULTRA1:| MFG DATE: 11/01/2013| EGIAADAPT: ENDO GIA ADAPTER STANDARD| LOT NUMBER N3L0141UX, K121510| LOT NUMBER: N3K1364UX, K121510,| MFG DATE: 10/01/2013