BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK® MULTI-USE HOLMIUM LASER FIBER

    MDR report key: 5344945 · Received January 5, 2016

    Report

    Report Number
    1820334-2016-00001
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    December 7, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER NOT PROVIDED BY THE REPORTER. EXPIRATION DATE UNKNOWN AS LOT IS UNKNOWN. UDI #: UNKNOWN AS LOT IS UNKNOWN. (B)(4). THE 510K#: K124030. EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION/EVALUATION: DURING THE COURSE OF THE INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, QUALITY CONTROL, INSTRUCTIONS FOR USE (IFU), AND TRENDS OF THE PRODUCT WAS CONDUCTED. THE DEVICE IS INSPECTED PER MANUFACTURING INSTRUCTIONS TO ENSURE THE INTEGRITY OF THE DEVICE. THE LOT NUMBER OF THE DEVICE WAS NOT RETURNED, THEREFORE REVIEW OF LOT RECORDS FOR THIS DEVICE COULD NOT BE EXECUTED. PER THE PROVIDED IFU; IT IS STATED: 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. NEVER SUBJECT FIBEROPTICS TO SHARP BENDS IN HANDLING, USE , OR STORAGE. ALWAYS KEEP CONNECTOR-END DRY AND FREE FROM CONTAMINANTS. DISCARD ANY FIBEROPTIC ASSEMBLY THAT IS CRACKED OR BROKEN, OR DOES NOT MEET MINIMUM TRANSMISSION STANDARDS. DO NOT EXCEED RECOMMENDED POWER LIMITS. WITHOUT THE RETURNED COMPLAINT DEVICE, THE ROOT CAUSE OF THE CUSTOMER'S DIFFICULTY CANNOT BE DETERMINED. PER THE RISK ASSESSMENT, THE RISK FOR THE TIP OF THE FIBER BREAKING HAS BEEN ASSESSED. NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    DURING A URETEROSCOPY PROCEDURE, UPON USE OF THE LASER, THE TIP BROKE OFF WITHIN THE PATIENT. THE PHYSICIAN RETRIEVED THE DEVICE PORTION. NO CONSEQUENCE TO PATIENT REPORTED.

    Description of Event or Problem · 1

    DURING A URETEROSCOPY PROCEDURE, UPON USE OF THE LASER, THE TIP BROKE OFF WITHIN THE PATIENT. THE PHYSICIAN RETRIEVED THE DEVICE PORTION. NO CONSEQUENCE TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4828 COOK® MULTI-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention