BEUDAMED
    FDA Adverse Event Other Summary report: N

    REPOSABLE STEP

    MDR report key: 162993 · Received April 17, 1998

    Report

    Report Number
    1721520-1998-00001
    Event Type
    Other
    Date Received
    April 17, 1998
    Date of Event
    March 12, 1998
    Report Date
    April 16, 1998
    Manufacturer
    INNERDYNE, INC.
    Product Code
    GCJ
    Removal / Correction Number
    900618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EPISODE OCCURRED DURING A LAPAROSCOPIC TUMOROUS FIBROIDECTOMY PROCEDURE ON A 43 YEAR OLD FEMALE PATIENT UNDER THE DIRECTION OF A DR. DURING REMOVAL OF A PORTION OF A UTERINE FIBROID FROM THE PATIENT, THE ATTENDING SURGEON NOTED THAT A 3MM X 3MM PIECE OF THE DISTAL END OF THE CANNULA BARREL HAD BEEN BROKEN FROM THE TERMINAL END OF THE BARREL AND HAD FALLEN OFF INTO THE ABDOMEN OF THE PATIENT. AN EXTENSIVE LAPAROSCOPIC SEARCH OF THE ADBOMINAL CAVITY WAS UNDERTAKEN, BUT THE DISLODGED PIECE COULD NOT BE LOCATED. THE ABDOMINAL REGION WAS FLUOROSCOPICALLY EXAMINED TWICE, ALSO RESULTING IN UNSUCCESSFUL LOCATION OF THE PIECE. THE PROCEDURE WAS BROUGHT TO CONCLUSION AND THE PATIENT WAS CLOSED, WITHOUT LOCATION OR RETRIEVAL OF THE MATERIAL. THE PATIENT WAS SATISFACTORILY CLOSED. TAKEN TO RECOVERY, AND IS REPORTED FINE AT THIS TIME WITHOUT MEDICAL SEQUELAE. THEREFORE, THE REPORTED EVENT IS DESCRIBED AS A SUSPICION OF LEAVING OF A FOREIGN MATERIAL IN THE ABDOMINAL REGION. SECONDARY SURGICAL INTERVENTION, ABOVE AND BEYOND THE ORIGINAL PROCEDURE, WAS NOT UNDERTAKEN. THE FRACTURED/DAMAGED BARREL WAS RETURNED TO INNERDYNE, INC., AND A FULL EXAMINATION HAS BEEN UNDERTAKEN AND DOCUMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPOSABLE STEP 12MM S/C/D GCJ INNERDYNE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other