BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 19671098 · Received July 3, 2024

    Report

    Report Number
    1820334-2024-00905
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    May 20, 2024
    Report Date
    October 24, 2024
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002482941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTED INFORMATION: D4, H6: MEDICAL DEVICE PROBLEM CODE (ANNEX A), COMPONENT CODE (ANNEX G). INVESTIGATION EVALUATION. DESCRIPTION OF EVENT: IT WAS REPORTED THAT AN NGAGE NITINOL STONE EXTRACTOR´S BASKET WAS UNABLE TO BE OPENED PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL (QC) PROCEDURES, AS WELL AS INTERVIEW PERSONNEL, A VISUAL INSPECTION, OF THE RETURNED DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. ONE NGAGE NITINOL STONE EXTRACTOR WAS RETURNED IN AN OPEN PACKAGE WITH LABEL. UPON INSPECTION NO SIGNIFICANT DAMAGE TO THE DEVICE WAS NOTICED. BASKET HAD BROKEN WIRES COMING FROM DISTAL END OF SHEATH. ADDITIONALLY, 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 DEVICE HISTORY RECORD (DHR) FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS ONE OTHER COMPLAINT SIMILAR WITH THE COMPLAINT DEVICE LOT. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, AND QUALITY CONTROL DOCUMENTS DID NOT PROVIDE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION OR TO SUGGEST ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE WERE NONCONFORMING. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, DID NOT PROVIDE ANY INFORMATION RELATED TO THE REPORTED ISSUE. THE RETURNED DEVICE WAS FOUND TO HAVE A BASKET THAT WOULD NOT OPEN DUE TO SEPARATION OF THE BASKET FROM THE BASKET SHEATH. THE SHRINK TUBE AND GLUE THAT SECURES THE BASKET TO THE BASKET SHEATH HAD NOT HELD THE TWO COMPONENTS TOGETHER. THE BASKET ASSEMBLY IS MANUFACTURED BY A SUPPLIER. THE SUPPLIER WAS INFORMED TO INVESTIGATE THE ISSUE. A CAUSE HAD NOT BEEN DETERMINED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING 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.

    Additional Manufacturer Narrative · 0

    G4 ¿ PMA/510(K) #: EXEMPT H3 - DEVICE EVALUATED BY MFG = OTHER (81) -DEVICE HAS BEEN RETURNED AND PRELIMINARY EVALUATION HAS BEEN PERFORMED, HOWEVER, OUR INVESTIGATION IS ONGOING AND DEVICE EVALUATION SUMMARY WILL BE INCLUDED IN OUR FOLLOW UP REPORT ONCE OUR INVESTIGATION HAS BEEN COMPLETED. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR´S BASKET WAS UNABLE TO BE OPENED PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930486 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G48294 15666105 10827002482941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown