BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS LAPAROSCOPIC

    MDR report key: 2902908 · Received November 30, 2012

    Report

    Report Number
    8010047-2012-00449
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    June 1, 1992
    Report Date
    November 1, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO. THE PHYSICIAN WOULD NOT PROVIDE ANY INFO DUE TO PENDING LITIGATION. NO DEVICE WAS AVAILABLE FOR EVAL DUE TO THE LENGTH OF TIME, 20 YEARS, BETWEEN THE PT'S PROCEDURE AND THE DISCOVERY OF THIS ALLEGED ROD LENS INSIDE THE PT'S CAVITY. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN EXCESS OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC LAPAROSCOPIC SURGERY ON (B)(6) 1992, A PIECE OF THE LAPAROSCOPE, ALLEGEDLY MANUFACTURED EITHER BY OLYMPUS AMERICA INC OR KARL STORZ ENDOSCOPY, BROKE OFF AND WAS LEFT IN THE PT'S BODY. THE PT HAD POSTOPERATIVE NAUSEA AND WAS ADMITTED OVERNIGHT FOR OBSERVATION. THE PT WAS DISCHARGED THE NEXT DAY. ADD'L TESTS WERE PERFORMED AND WERE NONCONCLUSIVE. ON (B)(6) 2012, A DIAGNOSTIC LAPAROSCOPY SURGERY WAS PERFORMED TO REMOVE THE FOREIGN OBJECT FROM THE PT. UPON EXAMINATION, THE FOREIGN OBJECT WAS IDENTIFIED BY THE USER FACILITY AS A ROD LENS. THE LENS WAS MOST LIKELY FROM THE TIP OF A LAPAROSCOPE BUT A MODEL COULD NOT BE DETERMINED DUE TO THE FACT THAT LAPAROSCOPES FROM 1992 ARE NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS LAPAROSCOPIC LAPAROSCOPE GCJ OLYMPUS MEDICAL SYSTEM CORPORATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK KARL STORZ LAPAROSCOPE: MODEL/SN UNK