BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK® MULTI-USE HOLMIUM LASER FIBER

    MDR report key: 5270491 · Received December 7, 2015

    Report

    Report Number
    1820334-2015-00857
    Event Type
    Injury
    Date Received
    December 7, 2015
    Date of Event
    November 19, 2015
    Report Date
    December 2, 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). INVESTIGATION / EVALUATION - NO PRODUCT WAS RETURNED TO ASSIST IN THE INVESTIGATION; HOWEVER, A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU) MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL (QC) AND TRENDS WAS CONDUCTED DURING THE COURSE OF INVESTIGATION. THE DEVICE IS INSPECTED TO ASSURE THAT NO BREAKS ARE PRESENT. AS THE LOT NUMBER WAS NOT PROVIDED, A 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. 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." BASED ON THE AVAILABLE LEVEL OF 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. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT AND WE WILL CONTINUE TO MONITOR FOR SIMILAR INCIDENTS. THERE WILL BE NO FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). K1240300. EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Description of Event or Problem · 1

    DURING AN URETEROSCOPY PROCEDURE, UPON LASER USE, THE TIP OF THE LASER FIBER BROKE WHILE WITHIN THE PATIENT. TO THE KNOWLEDGE OF THE REPORTER, THE DEVICE PORTION WAS ABLE TO BE RETRIEVED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DURING AN URETEROSCOPY PROCEDURE, UPON LASER USE, THE TIP OF THE LASER FIBER BROKE WHILE WITHIN THE PATIENT. TO THE KNOWLEDGE OF THE REPORTER, THE DEVICE PORTION WAS ABLE TO BE RETRIEVED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802320 COOK® MULTI-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention