BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 16387525 · Received February 16, 2023

    Report

    Report Number
    1820334-2023-00147
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    January 17, 2023
    Report Date
    April 6, 2023
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002482958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510K # ¿ EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: AS REPORTED, THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR WOULD NOT OPEN. ANOTHER NGAGE NITINOL STONE EXTRACTOR WAS USED TO COMPLETE THE UNSPECIFIED PROCEDURE. THE ISSUE WITH THIS DEVICE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND IT WAS NOT USED ON A PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. INVESTIGATION EVALUATION: REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU), AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS RETURNED TO COOK FOR EVALUATION IN OPEN PACKAGING. THE SUPPORT SHEATH IS SEPARATED 1 CM AND AGAIN AT 2 CM FROM NOSE OF MLLA (MALE LUER LOCK ADAPTER). THE HANDLE DOES NOT ACTUATE BASKET FORMATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHR FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, AND QUALITY CONTROL DOCUMENTS PROVIDE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU DID NOT PROVIDE ANY INFORMATION RELATED TO THE REPORTED ISSUE. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, THE CAUSE FOR THE OBSERVED DAMAGE COULD NOT BE DETERMINED. THE RETURNED DEVICE WAS FOUND TO HAVE A BASKET THAT WAS CLOSED AND COULD NOT BE OPENED DUE TO SHEATH DAMAGE. THE ORANGE SUPPORT SHEATH WAS FOUND TO BE FRACTURED/SEPARATED IN TWO LOCATIONS, PREVENTING THE DEVICE FROM FUNCTIONING. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    AS REPORTED, THE BASKET OF AN NGAGE NITINOL STONE EXTRACTOR WOULD NOT OPEN. ANOTHER NGAGE NITINOL STONE EXTRACTOR WAS USED TO COMPLETE THE UNSPECIFIED PROCEDURE. THE ISSUE WITH THIS DEVICE WAS DISCOVERED PRIOR TO PATIENT CONTACT AND IT WAS NOT USED ON A PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608082 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC N/A 14571938 10827002482958

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown