BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO CATCH

    MDR report key: 2782118 · Received October 3, 2012

    Report

    Report Number
    9612501-2012-00068
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 12, 2012
    Report Date
    September 6, 2012
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: A MALFUNCTION WITH THE ENDOCATCH POUCH, WHICH ENDED IN A RETAINED FOREIGN OBJECT. IT WAS CLEAR THAT THE "PLASTIC COLLAR" THAT WAS LEFT ON THE METAL RING AFTER THE POUCH WAS CINCHED. PATIENT NEEDED FOLLOW UP SURGERY WITHIN 3 WEEKS OF HER LAPAROSCOPIC CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ENDO CATCH SINGLE USE SPECIMEN RETRIEVAL PRODUCT GCJ COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other