BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 17059046 · Received June 5, 2023

    Report

    Report Number
    1820334-2023-00688
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    March 29, 2023
    Report Date
    September 6, 2023
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002482941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. CORRECTION: H6: MEDICAL DEVICE PROBLEM CODE (ANNEX A). EVENT DESCRIPTION: AS REPORTED, THE BASKET WIRE OF THE NGAGE NITINOL STONE EXTRACTOR BROKE DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME LIKE DEVICE. THERE WAS NO HARM TO THE PATIENT. INVESTIGATION - EVALUATION: REVIEWS OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), MANUFACTURING INSTRUCTIONS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THIS DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. 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) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: SUGGESTED HANDLING INSTRUCTIONS FOR EXTRACTORS AND FORCEPS CAUTION: THIS DEVICE IS CONDUCTIVE. AVOID CONTACT WITH ANY ELECTRIFIED INSTRUMENT. IMPORTANT: EXCESSIVE FORCE COULD DAMAGE DEVICE. THERE ARE MULTIPLE POSSIBLE CAUSES FOR THE REPORTED ISSUE OF A BROKEN BASKET WIRE. - THE BASKET WIRE MAY HAVE BEEN EXPOSED TO A LASER OR ELECTRIFIED DEVICE DURING USE, CAUSING THE WIRE TO HEAT UP AND BREAK. THE IFU CONTAINS A CAUTION THAT THE DEVICE IS CONDUCTIVE AND TO AVOID CONTACT WITH ANY ELECTRIFIED INSTRUMENTS. - EXCESSIVE FORCE MAY HAVE BEEN APPLIED TO THE DEVICE, CAUSING THE WIRE TO BREAK. SUCH AS ATTEMPTING TO PULL A LARGE STONE THROUGH THE SCOPE. THE IFU CONTAINS A NOTE THAT EXCESSIVE FORCE COULD DAMAGE THE DEVICE. THE CAUSE OF THE ISSUE WAS UNABLE TO 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 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 WIRE OF THE NGAGE NITINOL STONE EXTRACTOR BROKE DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETE WITH ANOTHER SAME LIKE DEVICE. THERE WAS NO HARM 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
    2293367 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 14872616 10827002482941

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown