BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE LIGHT 10/PK

    MDR report key: 4910568 · Received July 13, 2015

    Report

    Report Number
    0008010177-2015-00158
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 17, 2015
    Manufacturer
    STRYKER ENDOSCOPY-PUERTO RICO
    Product Code
    FTD
    PMA / PMN Number
    K961122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DISTAL BREAKAGE OF THE KNIFE LIGHT 10/PK COULD BE CONFIRMED. BASED ON THE INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE BREAKAGE OF THE DISTAL ARM OF THE POLYCARBONATE PIN WAS CAUSED BY A TENSION FORCE. THE OPERATIVE TECHNIQUE 982355-EN A4409 KNIFELIGHT OPTECH WAS REVIEWED: ¿WORKSHOP TRAINING IS REQUIRED PRIORI TO FIRST SURGERY¿. [ORIGINAL STATEMENTS] - THE INSTRUCTIONS FOR USE 3300-001-000 REV J KNIFELIGHT WERE REVIEWED: ¿DO NOT USE THE KNIFELIGHT AS A RETRACTING DEVICE TO PRY OR SEPARATE MUSCLE OR LIGAMENTS. USING THE DEVICE IN THIS MANNER MAY CAUSE THE TIP OF THE KNIFELIGHT TO BREAK OFF IN THE SURGICAL SITE AND MAY RESULT IN INJURY.¿ ¿THE KNIFELIGHT MUST ONLY BE USED BY PHYSICIANS WHO HAVE SPECIFIC ANATOMICAL AND SURGICAL SKILLS AND ARE EXPERIENCED IN HAND SURGERY.¿ ¿READ AND UNDERSTAND THESE INSTRUCTIONS. FAMILIARIZATION WITH KNIFELIGHT PRIOR TO USE IS IMPORTANT.¿ [ORIGINAL STATEMENTS] A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. THE OPERATION TECHNIQUE DOCUMENT AND THE IFUS HIGHLIGHT THE IMPORTANCE OF GETTING FAMILIAR WITH THE PRODUCT PRIOR TO BE USED AS WELL AS NOT SEPARATE TISSUES WITH THIS INSTRUMENT. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE TIP OF THE KNIFELIGHT BROKE DURING INITIAL STAGE OF SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    THE TIP OF THE KNIFE LIGHT BROKE DURING INITIAL STAGE OF SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452254 KNIFE LIGHT 10/PK SURGICAL LAMP FTD STRYKER ENDOSCOPY-PUERTO RICO 13262SE2

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other