BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPRO-CLIP 8MM LPW

    MDR report key: 275496 · Received April 26, 2000

    Report

    Report Number
    1219930-2000-00199
    Event Type
    Malfunction
    Date Received
    April 26, 2000
    Date of Event
    March 23, 2000
    Report Date
    March 28, 2000
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. REPORTEDLY, THE CLIPS DID NOT FORM PROPERLY. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPRO-CLIP 8MM LPW CLIP APPLIER GDO UNITED STATES SURGICAL CORPORATION NA C9G2820

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN