BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 16939755 · Received May 16, 2023

    Report

    Report Number
    1820334-2023-00606
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    May 4, 2023
    Report Date
    August 3, 2023
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002482972
    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, UNCHANGED, OR UNAVAILABLE. CORRECTED INFORMATION: H6: MEDICAL DEVICE PROBLEM CODE (ANNEX A) AND COMPONENT CODE (ANNEX G). EVENT DESCRIPTION: IT WAS REPORTED THAT A NGAGE NITINOL STONE EXTRACTOR WAS KINKED AND THE USER COULD NOT OPEN AND CLOSE THE DEVICE. THE ISSUE WAS NOTED PRIOR TO USE. 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. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), MANUFACTURING INSTRUCTIONS, THE INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES. ONE NGAGE NITINOL STONE EXTRACTOR WAS RETURNED FOR INVESTIGATION IN AN OPENED OUTER LABELED PACKAGE. INSPECTION OF THE RETURNED DEVICE NOTED: THE BASKET SHEATH WAS KINKED. A FUNCTIONAL TEST DETERMINED THE HANDLE DID NOT ACTUATE BASKET FORMATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. BECAUSE THERE WERE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING AND QUALITY CONTROL DOCUMENTS WAS CONDUCTED. ALL EXTRACTORS ARE VERIFIED TO ASSURE THE BASKET OPENS AND CLOSES PROPERLY. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INSTRUCTIONS FOR USE (IFU), DOES NOT PROVIDE ANY INFORMATION RELATED TO THE REPORTED ISSUE. THE RETURNED DEVICE WAS FOUND TO HAVE A BASKET THAT DID NOT FUNCTION DUE TO SHEATH DAMAGE. THE CAUSE OF THE OBSERVED DAMAGE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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. E3: CUSTOMER OCCUPATION = "SUPERVISOR; (SUPERVISORA DE RRMM)". G4: PMA/510(K) NUMBER = 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 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

    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 THAT A 'NGAGE NITINOL STONE EXTRACTOR' WAS KINKED AND THE USER COULD NOT OPEN AND CLOSE THE DEVICE. THE ISSUE WAS NOTED PRIOR TO USE. 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
    1863930 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 15168416 10827002482972

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown