BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUYS HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 2526953 · Received March 30, 2012

    Report

    Report Number
    8010047-2012-00098
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 1, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE REFERENCED DEVICE WAS INSPECTED DURING PREPARATION AND IT WAS NOTICED THAT A TINY PIECE OF GRAY RUBBER WAS CRACKED AT THE HEAD BUT THE IMAGE WAS REPORTEDLY FINE. AFTER THE PROCEDURE WAS STARTED, THE IMAGE REPORTEDLY BEGAN FLICKERING AND WENT BLACK TWICE. THE REFERENCED DEVICE WAS SAID TO HAVE BEEN REMOVED AND THE INTENDED PROCEDURE WAS DELAYED UNTIL A REPLACEMENT DEVICE COULD BE OBTAINED. THERE WAS REPORTEDLY AN ADDITIONAL 10-15 MINUTES OF ANESTHESIA TIME FOR THE PATIENT. THE REFERENCED DEVICE WAS SAID TO HAVE BEEN UTILIZED IN CONJUNCTION WITH AN UNIDENTIFIED OLYMPUS 10MM TELESCOPE AND THE TELESCOPE WAS REPORTEDLY WORKING FINE. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS (B)(4) FOR EVALUATION. THE EVALUATION CONFIRMED THE USER'S REPORT. THERE WERE TWISTED SECTIONS IN THE CABLE WHICH CAUSED INTERFERENCE WHEN THE CABLE WAS MOVED. THE DAMAGE TO THE CABLE APPEARS TO BE DUE TO PHYSICAL DAMAGE. THE REFERENCED DEVICE WAS REPLACED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE IMAGE WAS FLICKERING TO THE POINT THAT THE USERS COULD NO LONGER VIEW THE PATIENT'S ANATOMY. THE PATIENT WAS SAID TO HAVE BEEN ANESTHETIZED WITH INCISIONS MADE TO THE ABDOMEN. THE USERS REPORTEDLY SAW A FINE CRACK IN THE RUBBER CONNECTION, AND THE INTENDED PROCEDURE WAS SAID TO HAVE BEEN DELAYED AS IT WAS COMPLETED WITH DIFFERENT, UNIDENTIFIED MODEL OF CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUYS HD AUTOCLAVABLE CAMERA HEAD CAMERIA HEAD KQM OLYMPUS MEDICAL SYSTEMS CORPORATION OTV-S7PROH-HD-12E NA

    Patients

    Seq Age Sex Outcome Treatment
    1