BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE PREMIUM SURGICLIP M-9.75

    MDR report key: 126364 · Received October 8, 1997

    Report

    Report Number
    2647580-1997-01239
    Event Type
    Malfunction
    Date Received
    October 8, 1997
    Report Date
    September 10, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    11/05/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE CLIPS DID NOT LOAD PROPERLY. THE SURGEON USE ANOTHER INSTRUMENT TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM SURGICLIP M-9.75 DISPOSABLE CLIP APPLIER GAG UNITED STATES SURGICAL CORP NA P6H436

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN