BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULATING SCOPE, NTSC VERSION

    MDR report key: 5736982 · Received June 20, 2016

    Report

    Report Number
    0002936485-2016-00565
    Event Type
    Malfunction
    Date Received
    June 20, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 26, 2016
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HET
    PMA / PMN Number
    K082451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE DEVICE MANUFACTURER DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. (B)(4).

    Additional Manufacturer Narrative · 1

    ALLEGED FAILURE: TIP OF SCOPE FELL INSIDE PATIENT. CONFIRMED FAILURE: CCD SENSOR REPLACEMENT MISHANDLING, CUT VITON REPAIR MISHANDLING. PROBABLE ROOT CAUSE: MANUFACTURING NONCONFORMITY; TEAR/CUT IN VITON; SCRATCH/OBSTRUCTION ON OPTICS; LOOSE THREAD ON VITON; ROUGH / CHIPPING SURFACES; USE ERROR . THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MFG DATE: 10/30/2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLASTIC TIP OF THE DEVICE PEELED OFF INSIDE THE PATIENT. ALL THE PLASTIC WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLASTIC TIP OF THE DEVICE PEELED OFF INSIDE THE PATIENT. ALL THE PLASTIC WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391779 ARTICULATING SCOPE, NTSC VERSION LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1