BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 20086231 · Received August 28, 2024

    Report

    Report Number
    1820334-2024-01129
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 14, 2024
    Report Date
    November 25, 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

    E1: (B)(6). E1: POSTAL CODE: (B)(6). E1: PHONE: (B)(6). E1: MOBILE: (B)(6). G4 ¿ PMA/510(K) #: 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTIONS: D10: CONCOMITANT PRODUCTS. H6: ANNEX A AND G. INVESTIGATION - EVALUATION IT WAS REPORTED THE 'NGAGE NITINOL STONE EXTRACTORS' BASKET SHAPE WAS "ABNORMAL" PRIOR TO KIDNEY STONE REMOVAL PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. THE DEVICE WAS CHECKED PRIOR TO USE IT. THE ISSUE WAS FOUND WHEN THE DEVICE WAS OPENED AND CLOSED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS (MI), AND QUALITY CONTROL (QC) PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. INTERVIEW OF PERSONNEL WAS ALSO CONDUCTED. FUNCTIONAL TESTS AND VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE WAS ALSO CONDUCTED. ONE, 'NGAGE NITINOL STONE EXTRACTOR' WAS RETURNED FOR INVESTIGATION IN AN OPEN PACKAGE WITH LABEL. BASKET WIRES APPEAR TO HAVE BEEN STRETCHED AND PULLED AND THE CLEAR SHEATH IS PULLED AWAY FROM THE WIRES. COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. 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 RELATED NON-CONFORMANCES REPORTED FOR LOT. A COMPLAINT HISTORY DATABASE SEARCH SHOWED ONE OTHER RELATED COMPLAINT ASSOCIATED WITH THE FAILURE MODE FOR THE COMPLAINT DEVICE LOT. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED. ONE OTHER LOT RELATED COMPLAINT HAS BEEN RECEIVED FROM THE FIELD. THIS COMPLAINT IS RELATED TO THE CURRENT FAILURE MODE. COOK ALSO REVIEWED PRODUCT LABELING; THE IFU SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: "SUGGESTED HANDLING INSTRUCTIONS FOR EXTRACTORS AND FORCEPS: IMPORTANT: EXCESSIVE FORCE COULD DAMAGE DEVICE." THE RETURNED DEVICE WAS FOUND TO HAVE THE BASKET SHEATHS THAT HOLD THE BASKET WIRES IN PLACE SPLIT, PREVENTING THE BASKET FROM HAVING THE PROPER SHAPE. THE PROVIDED INFORMATION STATED THE ISSUE WAS FOUND BEFORE USE OF THE DEVICE. BASED UPON THE AVAILABLE INFORMATION, INSPECTION OF THE RETURNED DEVICE, AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE FOR THE COMPLAINT COULD NOT BE ESTABLISHED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NGAGE NITINOL STONE EXTRACTOR'S BASKET SHAPE WAS "ABNORMAL" PRIOR TO KIDNEY STONE REMOVAL PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. THE DEVICE WAS CHECKED PRIOR TO USE IT. THE ISSUE WAS FOUND WHEN THE DEVICE WAS OPENED AND CLOSED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.

    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
    128312 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC G48294 15953973 10827002482941

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female COOK URETERAL SHEATH (UNSPECIFIED)| OLYMPUS V2