BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO CLIP 5MM

    MDR report key: 159891 · Received March 25, 1998

    Report

    Report Number
    1219161-1998-00560
    Event Type
    Malfunction
    Date Received
    March 25, 1998
    Report Date
    February 23, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    1/25/1999- SUPPLEMENTAL #1 SENT TO FDA. DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING A CHOLECYSTECTOMY PROCEDURE. REPORTEDLY, THE CLIPS DID NOT ADVANCE PROPERLY. THE SURGEON APPLIED ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO CLIP 5MM DISPOSABLE CLIP APPLIER GCJ UNITED STATES SURGICAL CORP. NA U7H76M

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN