BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® MULTI-USE HOLMIUM LASER FIBER

    MDR report key: 8600158 · Received May 10, 2019

    Report

    Report Number
    1820334-2019-01039
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Report Date
    July 5, 2019
    Manufacturer
    COOK INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, SPECIFICATIONS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. ADDITIONALLY, AN IFU IS PROVIDED WITH THE DEVICE, WHICH PROVIDES ALL THE PROPER WARNINGS, PRECAUTIONS, INDICATIONS, AND CONTRAINDICATIONS FOR THE DEVICE. BASED ON THE LACK OF INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT A ROOT CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER OCCUPATION - MANAGER. PMA/510K # K133788. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED DURING A BLADDER STONE REMOVAL PROCEDURE USING A COOK® MULTI-USE HOLMIUM LASER FIBER, THE TIP OF THE FIBER BROKE UPON FIRST FIRING. A NEW FIBER WAS OPENED AND USED TO COMPLETE THE CASE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS ISSUE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THIS ALLEGED PRODUCT MALFUNCTION. THERE WAS NO INJURY TO THE STAFF/END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394446 COOK® MULTI-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1