BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE VERSAPORT RPF 5-12MM

    MDR report key: 134436 · Received November 20, 1997

    Report

    Report Number
    1219161-1997-01726
    Event Type
    Malfunction
    Date Received
    November 20, 1997
    Date of Event
    October 21, 1997
    Report Date
    October 24, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    10/7/1998- SUPPLEMENTAL REPORT SENT TO FDA. CORRECTED DATA ENTERED ON D-9. PRODUCT CODES ENTERED IN H-3 AND H-6 INDICATING THE PRODUCT WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE TROCARS WERE SPLIT CAUSING AN AIR LOSS. NO PT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE VERSAPORT RPF 5-12MM DISPOSABLE TROCAR GCJ UNITED STATES SURGICAL CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN