BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE TA 90-3.5

    MDR report key: 165085 · Received April 28, 1998

    Report

    Report Number
    1219161-1998-00785
    Event Type
    Malfunction
    Date Received
    April 28, 1998
    Report Date
    March 31, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    10/13/1998- SUPPLEMENTAL REPORT SENT TO FDA. ADDITIONAL DATA ENTERED IN D-6 (CATALOG #).

    Description of Event or Problem · 1

    REPORTEDLY, THE INSTRUMENT DID NOT STAPLE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE TA 90-3.5 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN