BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE MULTIFIRE ENDO GIA 30-2.5

    MDR report key: 91620 · Received May 14, 1997

    Report

    Report Number
    2647580-1997-00499
    Event Type
    Malfunction
    Date Received
    May 14, 1997
    Date of Event
    April 15, 1997
    Report Date
    April 15, 1997
    Manufacturer
    USSC PUERTO RICO, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    6/23/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC SIGMOID RESECTION PROCEDURE, THE KNIFE ASSEMBLY DID NOT ADVANCE. THE SURGEON USED ANOTHER DEVICE WITHOUT PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE MULTIFIRE ENDO GIA 30-2.5 DISPOSABLE SURGICAL STAPLER GCJ USSC PUERTO RICO, INC. NA P6L26

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN