BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRAUMATIC FUNDUS GRASPING INSERTS

    MDR report key: 571086 · Received January 26, 2005

    Report

    Report Number
    2027111-2005-00002
    Event Type
    Injury
    Date Received
    January 26, 2005
    Date of Event
    December 30, 2004
    Report Date
    January 24, 2005
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE APPLIED 5MM GRASPER WAS REMOVED FROM THE PATIENT AND HANDED TO THE SCRUB NURSE WHO NOTICED THE INSERT WAS MISSING. DOCTOR ESTIMATED HE SPENT 45 MINUTES SEARCHING LAPAROSCOPICALLY FOR THE INSERT BUT COULD NOT FIND IT. PATIENT WAS OBESE, ADDING TO THE DIFFICULTY, AN X-RAY OF THE PATIENT'S ABDOMEN WAS TAKEN IN RECOVERY, BUT THE INSERT COULD NOT BE OBSERVED. AN X-RAY OF INSERTS WAS ALSO TAKEN FOR COMPARATIVE REFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRAUMATIC FUNDUS GRASPING INSERTS A-TRAC GRASPER INSERTS HET APPLIED MEDICAL RESOURCES CORP. C4103 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening