BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE TA 30 PREMIUM V3

    MDR report key: 36974 · Received August 29, 1996

    Report

    Report Number
    1219161-1996-00005
    Event Type
    Malfunction
    Date Received
    August 29, 1996
    Date of Event
    July 26, 1996
    Report Date
    August 29, 1996
    Manufacturer
    UNITES STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    1/22/97 - SUPPLEMENTAL REPORT #3 SENT TO FDA. IT HAS COME TO CO'S ATTENTION THAT ON JANUARY 10, 1997, A SUPPLEMENTAL REPORT WAS CORRECTLY SUBMITTED UNDER THIS REGISTRATION NUMBER. PLEASE DISREGARD THAT REPORT AND REFER TO THE ONE SUBMITTED ON SEPTEMBER 24, 1996 FOR THE CORRECT INFORMATION.

    Description of Event or Problem · 1

    DEVICE WAS USED DURING A PNEUMONECTOMY PROCEDURE INVOLVING ONE PT. REPORTEDLY, STAPLES DID NOT FORM PROPERLY DURING APPLICATION RESULTING IN BLEEDING FROM THE STAPLE LINE. THE APPLICATION SITE WAS OVERSEWN AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THE HOSP HAS REPORTED NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE TA 30 PREMIUM V3 DISPOSABLE LOADING UNIT GAG UNITES STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN AUTO SUTURE TA 30 PREMIUM INSTRUMENT.