BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDEAL EYES PRECISION HD, 4MM, 30 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM,

    MDR report key: 4695914 · Received April 15, 2015

    Report

    Report Number
    0002936485-2015-00292
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    February 17, 2015
    Report Date
    February 23, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K093677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SCOPE WAS NOT RECEIVED FOR EVALUATION AT STRYKER ENDOSCOPY. THIS SCOPE WAS RECEIVED AT HENKE FOR EVALUATION. BASED ON THE HENKE SERVICE RECORD ATTACHED, THE REPORTED FAILURE FOGGY WAS CONFIRMED. VISUAL INSPECTION SCOPE WAS EVALUATED BY EYE AND WITH EYE LOUPE TO DETERMINE THE SCOPE HAS PIECE OF DISTAL TIP MISSING, BROKEN ROD LENSES, DENT ON OUTER TUBE NEEDLE AND BENT NEEDLE. FUNCTIONAL INSPECTION: WHEN LOOKING THROUGH THE EYEPIECE WITH EYE LOUPE INTERNAL LINES FROM BROKEN ROD LENSES CAN BE SEEN, CAUSING A BLURRY IMAGE. BASED ON PREVIOUS COMPLAINTS, A POSSIBLE ROOT CAUSE FOR THIS FAILURE IS: DAMAGED DISTAL TIP, BROKEN ROD LENSES, BENT OUTER TUBE NEEDLE DAMAGE OCCURRED DURING USE / HANDING BY THE CUSTOMER. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    "THIS SCOPE WAS NOT RECEIVED FOR EVALUATION AT STRYKER ENDOSCOPY. THIS SCOPE WAS RECEIVED AT HENKE FOR EVALUATION. BASED ON THE HENKE SERVICE RECORD, THE REPORTED FAILURE FOGGY WAS CONFIRMED.VISUAL INSPECTION SCOPE WAS EVALUATED BY EYE AND WITH EYE LOUPE TO DETERMINE THE SCOPE HAS PIECE OF DISTAL TIP MISSING, BROKEN ROD LENSES, DENT ON OUTER TUBE NEEDLE AND BENT NEEDLE. FUNCTIONAL INSPECTION: WHEN LOOKING THROUGH THE EYEPIECE WITH EYE LOUPE INTERNAL LINES FROM BROKEN ROD LENSES CAN BE SEEN, CAUSING A BLURRY IMAGE.BASED ON PREVIOUS COMPLAINTS, A POSSIBLE ROOT CAUSE FOR THIS FAILURE IS: DAMAGED DISTAL TIP, BROKEN ROD LENSES, BENT OUTER TUBE NEEDLE DAMAGE OCCURRED DURING USE / HANDING BY THE CUSTOMER.THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVIECE IS CONSISTENTLY FOGGING. DEVICE EVALUATION COMFIRMED THAT THE SCOPE HAS A PIECE OF DISTAL TIP MISSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE IS CONSISTENTLY FOGGING. DEVICE EVALUATION CONFIRMED THAT THE SCOPE HAS A PIECE OF DISTAL TIP MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249836 IDEAL EYES PRECISION HD, 4MM, 30 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1