BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHIBA BIOPSY NEEDLE

    MDR report key: 6109766 · Received November 17, 2016

    Report

    Report Number
    1820334-2016-01346
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    September 15, 2016
    Report Date
    August 11, 2017
    Manufacturer
    COOK INC
    Product Code
    KNW
    UDI-DI
    00827002010475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT CODE: MJG. COMMON NAME: DEVICE, PERCUTANEOUS, BIOPSY. (B)(4). CORRECTED DATA: INITIAL AWARE DATE IS 10/26/2016. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, MANUFACTURING INSTRUCTION, QUALITY CONTROL, AND SPECIFICATIONS WAS COMPLETED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED THAT DURING AN EXTERNAL PERCUTANEOUS BILIARY DRAINAGE, THE BIOPSY NEEDLE CAUGHT THE MANDREL AT THE TIME OF PUNCTURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BIOPSY NEEDLE CAUGHT THE MANDREL AT THE TIME OF PUNCTURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. 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
    762258 CHIBA BIOPSY NEEDLE KNW COOK INC N/A 00827002010475

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR