BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE VASCULAR LINEAR STAPLER

    MDR report key: 177540 · Received July 15, 1998

    Report

    Report Number
    1527736-1998-02037
    Event Type
    Malfunction
    Date Received
    July 15, 1998
    Date of Event
    June 17, 1998
    Report Date
    July 1, 1998
    Manufacturer
    ETHICON ENDO-SURGERY- ALB
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE DEVICE WAS USED DURING A ZENKER'S DIVERTICULUM OF THE ESOPHAGUS RESECTION. IT WAS REPORTED A TLV30 VASCULAR LINEAR STAPLER WAS PLACED ACROSS THE DIVERTICULUM. IT WAS CLOSED & FIRED. THE SPECIMEN WAS CUT WITH A SCALPEL. THE SURGEON DISCOVERED THAT THERE WAS NO STAPLE LINE. SURGEON CLAIMS THERE WERE NO STAPLES IN THE STAPLER. 07/02/1998 THE SURGEON COMPLETED THE PROCEDURE USING SUTURES. THERE WAS NO CONSEQUENCE TO THE PT. 07/02/1998 CONTACT PERSON REACHED VIA PHONE & HAD NOTHING FURTHER TO ADD TO ABOVE INFO OTHER THAN TO SAY THE SURGEON DID WANT TO KNOW THE OUTCOME OF THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE VASCULAR LINEAR STAPLER LINEAR STAPLER GAG ETHICON ENDO-SURGERY- ALB NA L49A9U

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other