BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 4919538 · Received July 10, 2015

    Report

    Report Number
    1820334-2015-00422
    Event Type
    Injury
    Date Received
    July 10, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 23, 2015
    Manufacturer
    COOK, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (B)(6). K124030 (B)(4). INVESTIGATION A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL (QC) AND A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS CONDUCTED FOR THE PURPOSE OF THIS INVESTIGATION. A VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMED THAT THE FIBER WAS SEPARATED INTO TWO SECTIONS. THE DISTAL TIP OF THE FIBER APPEARS INTACT AND NO VISUAL DAMAGE WAS APPARENT. THE SHEATH AT THE POINT OF SEPARATION APPEARED STRAINED, THUS INDICATING THE FIBER EXPERIENCED HIGH STRESS AT THAT POINT. IT IS POSSIBLE THAT THE LASER FIBER EXPERIENCED A COMBINATION OF SHEAR AND TENSILE FORCES DURING ITS ADVANCEMENT INTO THE PATIENT. THE FORCES AT THE POINT OF SEPARATION COULD HAVE RESULTED FROM EITHER A TWISTING AND/OR BENDING MOTION AT THAT PARTICULAR POINT. THIS WOULD CREATE A CONCENTRATION OF SHEAR AND TENSILE STRESS ON THE FIBER CAUSING EVENTUAL DEFORMATION THROUGH NECKING AND DRAWING. THE SHEATH PULLING APART WOULD HAVE EXPOSED THE LASER FIBER, THUS PROVIDING THE OPPORTUNITY FOR THE SURGEON TO BURNT ON THE ARM AS STATED IN THE EVENT DESCRIPTION. THE LASER FIBER IS INSPECTED TO ENSURE THE PROPER PLACEMENT WITHIN THE PACKAGING TO PREVENT ANY DAMAGE TO THE LASER FIBER AND/OR SHEATH. THE IFU PRECAUTIONS THAT IMPROPER HANDLING CAN AFFECT THE LIFE OF ANY FIBER AND TO NEVER SUBJECT THE FIBER OPTICS TO SHARP BENDS IN HANDLING, USE OR STORAGE. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. BASED ON THE INVESTIGATION, THE ROOT CAUSE HAS BEEN DETERMINED TO BE A RESULT OF EXCESSIVE PRESSURE AT A PARTICULAR POINT DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE FIBER BROKE OFF AT THE SHEATH'S END DURING THE PROCEDURE. THE SURGEON WAS BURNT ON THE ARM. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    THE FIBER BROKE OFF AT THE SHEATH'S END DURING THE PROCEDURE. THE SURGEON WAS BURNT ON THE ARM. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448893 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK, INC. N/A 5681376

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other