BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 6670246 · Received June 27, 2017

    Report

    Report Number
    1820334-2017-01440
    Event Type
    Malfunction
    Date Received
    June 27, 2017
    Date of Event
    May 25, 2017
    Report Date
    October 9, 2017
    Manufacturer
    COOK INC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE NGAGE NITINOL STONE EXTRACTOR WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT IDENTIFY ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. A REVIEW OF COMPLAINT HISTORY FOR THE PRODUCT AND LOT NUMBER COMBINATION COULD NOT BE COMPLETED WITHOUT THE LOT NUMBER. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION EVALUATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    PRIOR TO PERFORMING A LASER LITHOTRIPSY WITH BASKET STONE EXTRACTION AND STENT PLACEMENT PROCEDURE, THE PHYSICIAN OPENED A PACKAGE CONTAINING AN NGAGE NITINOL STONE EXTRACTOR. THE PHYSICIAN TESTED THE DEVICE AND FOUND THAT THE DEVICE FAILED TO OPEN. THIS OCCURRED WITH TWO SEPARATE DEVICES, THE LOT OF BOTH IS UNKNOWN. THE DEVICE DID NOT COME IN CONTACT WITH THE PATIENT. 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
    450607 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1