BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOCONTROL ARTHROSCOPY PUMP (HAND CONTROL INCLUDED)

    MDR report key: 4802378 · Received May 28, 2015

    Report

    Report Number
    0002936485-2015-00428
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 18, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K030402
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) WAS NOT RECEIVED FOR INVESTIGATION AT STRYKER ENDOSCOPY BECAUSE IT WAS REPAIRED LOCALLY AT STRYKER (B)(4) SERVICE CENTER; THEREFORE THE REPORTED FAILURE CANNOT BE CONFIRMED. THE COMPLAINT WILL BE CLOSED WITHOUT A DETAILED INVESTIGATION REPORT AND BASED ON PROBABLE ROOT CAUSE. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED, A FULL EVALUATION WILL BE CONDUCTED, AND THE INVESTIGATION WILL BE UPDATED WITH THE NEW RESULTS. THE TECHNICAL SERVICE REPORT WAS USED AND INDICATES: ROLLER WHEEL 2400195 - WORN OUT, REPLACEMENT REQUIRED, PRESSURE SENSORS SET 2400066 2200856 - DAMAGED, REPLACEMENT REQUIRED. CALIBRATION + FUNCTIONAL TEST + SAFETY TEST. THE REPORTED EVENT INVOLVING THIS FAILURE AND DEVICE COULD HAVE BEEN CAUSED BY: SOFTWARE (3, 3.1, 3.4 FOR CF, OR RELATED MODULES IN OTHER PUMPS). MAIN BOARD FAILURE. FRONT BOARD FAILURE. IMX MODULE FAILURE (CF). LCD TOUCH PANEL FAILURE (CF, FS). ESD ONTO TOUCH SCREEN (CF, FS). BAD TOUCH SCREEN CALIBRATION (CF, FS). FLUID INGRESS DAMAGES ELECTRICAL COMPONENTS. USE ERROR. SCREEN CRACKED. CONSOLE TOO SENSITIVE TO EM EMISSIONS. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PUMP STOPPED OPERATING DURING SURGERY. AS PER THE CUSTOMER THE PUMP DISPLAYS ERROR 145. ACCORDING TO THE CUSTOMER THERE WAS NO DELAY TO SURGERY MORE THAN 30 MINUTES, THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT OR USER, THE SURGERY WAS COMPLETED SUCCESSFULLY HOWEVER MEDICAL INTERVENTION WAS NEEDED TO COMPLETE THE SURGERY

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PUMP STOPPED OPERATING DURING SURGERY. AS PER THE CUSTOMER THE PUMP DISPLAYS ERROR 145. ACCORDING TO THE CUSTOMER THERE WAS NO DELAY TO SURGERY MORE THAN 30 MINUTES, THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT OR USER, THE SURGERY WAS COMPLETED SUCCESSFULLY HOWEVER MEDICAL INTERVENTION WAS NEEDED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347322 FLOCONTROL ARTHROSCOPY PUMP (HAND CONTROL INCLUDED) ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other