BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK® MULTI-USE HOLMIUM LASER FIBER

    MDR report key: 5343338 · Received January 5, 2016

    Report

    Report Number
    1820334-2016-00002
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    November 30, 2015
    Report Date
    December 17, 2015
    Manufacturer
    COOK INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    LOT NUMBER NOT PROVIDED BY THE REPORTER. EXPIRATION DATE UNKNOWN AS LOT IS UNKNOWN. UDI #: UNKNOWN AS LOT IS UNKNOWN. (B)(4). 510K#: K124030. INVESTIGATION RESULTS: A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL (QC), MANUFACTURING INSTRUCTIONS (MI) AND TRENDS WAS CONDUCTED FOR THE PURPOSE OF THIS INVESTIGATION. THE DEVICE WAS NOT RETURNED TO ASSIST WITH THIS INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED REGARDING PATIENT OUTCOME, HOWEVER ADDITIONAL INFORMATION WAS NOT RECEIVED AT THE TIME THIS REPORT WAS COMPLETED. PER QC SPECIFICATIONS, THE DEVICE WAS INSPECTED TO ENSURE NO BREAKS ARE PRESENT ALONG THE FIBER LENGTH AND GREEN OUTPUT FROM END OF FIBER CREATES A WELL-DEFINED CIRCLE. THESE FIBERS ARE PACKAGED INSIDE A COILED HOLDER AND SNAPPED SECURELY IN THE PACKAGING TRAY. THE LOT NUMBER OF THE DEVICE WAS NOT RETURNED, THEREFORE REVIEW OF LOT RECORDS FOR THIS DEVICE COULD NOT BE EXECUTED. SPECIFIC TO THIS CASE THE PRODUCT IFU DETAILS: A NUMBER OF DIFFERENT FACTORS AFFECT THE LIFE OF ANY PARTICULAR FIBER, INCLUDING: EXTENDED LASING AT HIGH POWER; CONTINUOUS LASING WITH THE FIBER TIP IN CONTACT WITH TISSUE; POOR REPROCESSING (MINIMUM LENGTH OF FIBER REMOVED IN REPROCESSING SHOULD BE BETWEEN 2.5 AND 3 INCHES); LASING WITH A CONTAMINATED OR DAMAGE PROXIMAL END; IMPROPER HANDLING; POOR LASER BEAM ALIGNMENT OR FOCUS. SUBJECT FIBER OPTICS TO SHARP BENDS IN HANDLING, USE, OR STORAGE. ALWAYS KEEP CONNECTOR-END DRY AND FREE FROM CONTAMINANTS. DISCARD ANY FIBER OPTIC ASSEMBLY THAT IS CRACKED OR BROKEN, OR DOES NOT MEET MINIMUM TRANSMISSION STANDARDS. DO NOT EXCEED RECOMMENDED POWER LIMITS." THERE IS NO EVIDENCE TO SUGGEST THIS DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER IT IS POSSIBLE THAT THIS DEVICE BECAME DAMAGED DURING USE, RE-STERILIZATION AT THE USER FACILITY, OR DURING HANDLING OF THE DEVICE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED.

    Description of Event or Problem · 1

    DURING A URETEROSCOPY PROCEDURE, WHEN USING THE LASER, THE TIP BROKE OFF WITHIN THE PATIENT. THE PHYSICIAN DID NOT SPEND TIME RETRIEVING IT AS IT WAS NOT NOTICED PRIOR TO COMPLETION OF THE CASE. NO ADDITIONAL INFORMATION PROVIDED REGARDING PATIENT OUTCOME.

    Description of Event or Problem · 1

    DURING A URETEROSCOPY PROCEDURE, WHEN USING THE LASER, THE TIP BROKE OFF WITHIN THE PATIENT. THE PHYSICIAN DID NOT SPEND TIME RETRIEVING IT AS IT WAS NOT NOTICED PRIOR TO COMPLETION OF THE CASE. NO ADDITIONAL INFORMATION PROVIDED REGARDING PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4745 COOK® MULTI-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other