BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 16644322 · Received March 30, 2023

    Report

    Report Number
    1820334-2023-00348
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 21, 2023
    Report Date
    June 21, 2023
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    10827002482965
    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. CORRECTION: D10 - CONCOMITANT PRODUCTS; H6 - ANNEX G EVENT SUMMARY IT WAS REPORTED THAT THE BASKET OF A NGAGE NITINOL STONE EXTRACTOR WOULD NOT OPEN DURING A FLEXIBLE URETERORENOSCOPY (URS). THE DEVICE WAS TESTED PRIOR TO USE IN THE UNCOILED POSITION. A LASER WAS NOT USED DURING THE PROCEDURE. NO ATTEMPT WAS MADE TO CLOSE THE BASKET PRIOR TO REMOVAL FROM THE PLASTIC TRAY. A PUSEN SINGLE SCOPE WAS USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NEW BASKET. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION ¿ EVALUATION A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL PROCEDURES, AS WELL AS, A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE DEVICE WERE CONDUCTED. NINE DEVICES WERE RETURNED: TWO IN AN OPEN PACKAGE WITH LABEL AND SEVEN IN UNOPENED PACKAGES WITH LABELS TO COOK FOR INVESTIGATION. UPON INSPECTION 1 AND 2 HAD SOME DAMAGE TO THE PROXIMAL END OF THE SHEATH. BOTH DEVICES WERE RETURNED CLOSED. WHEN ACTUATING THE HANDLE, THE BASKETS DID NOT OPEN/CLOSE. DEVICES 3-9 WERE OPENED; UPON INSPECTION NO DAMAGE WAS NOTICED TO THE DEVICES. THE BASKETS WERE ALL IN OPEN POSITION. WHEN THE HANDLE WAS ACTUATED WITH ALL 7 DEVICES THE BASKETS OPENED/CLOSED PROPERLY. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED. NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PRODUCT LOT. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THE CAUSE FOR THE DAMAGE WAS UNKNOWN. EXCESSIVE FORCE MAY HAVE BEEN INADVERTENTLY APPLIED TO THE DEVICE; HOWEVER, NO INFORMATION WAS KNOWN REGARDING DEVICE HANDLING, THEREFORE THE CAUSE OF THE ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER A REVIEW OF RISK DOCUMENTATION, 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CUSTOMER PHONE: (B)(6). CUSTOMER OCCUPATION = UNKNOWN. 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 THE BASKET OF A NGAGE NITINOL STONE EXTRACTOR WOULD NOT OPEN DURING A FLEXIBLE URETERORENOSCOPY (URS). THE DEVICE WAS TESTED PRIOR TO USE IN THE UNCOILED POSITION. A LASER WAS NOT USED DURING THE PROCEDURE. NO ATTEMPT WAS MADE TO CLOSE THE BASKET PRIOR TO REMOVAL FROM THE PLASTIC TRAY. A PUSEN SINGLE SCOPE WAS USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A NEW BASKET. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173545 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC 15159846 10827002482965

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PUSEN SINGLE SCOPE