BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR STAPLER

    MDR report key: 162818 · Received April 13, 1998

    Report

    Report Number
    1527736-1998-01107
    Event Type
    Malfunction
    Date Received
    April 13, 1998
    Date of Event
    March 13, 1998
    Report Date
    March 17, 1998
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.50553. EES #.981920/A. D5,6; H4: INFORMAITON NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TL30 WAS USED DURING A LEFT UPPER LOBECTOMY(BRONCHUS). IT WAS REPORTED BY THE AFFILIATE THAT THE STAPLER WAS FIRED, STAPLES SEEMED TO FORM UPON INSPECTION. HOWEVER THERE WAS A LARGE HOLE IN THE BRONCHUS WHICH HAD TO BE QUICKLY SUTURED UP. ALL INDICATIONS FROM THE SURGEON WAS THAT HE WAS WITHIN ALL APPROPRIATE MEASURES TO FIRE THE GUN. HE DOES NOT KNOW WHY THE STAPLES DID NOT FORM AND OR HOLD. THE TISSUE WAS NOT TO THICK. THE SURGEON IS CONFIDENT HE WAS WITHIN THE ZONE OF FIRE. REP IS WAITING FOR STAPLER TO BE RELEASED. THE PT HAD EXTENDED SURGERY FOR 20-30 MINUTES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other