BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 17550370 · Received August 15, 2023

    Report

    Report Number
    1820334-2023-01091
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Report Date
    November 3, 2023
    Manufacturer
    COOK INC
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. EVENT SUMMARY A REPRESENTATIVE OF FULLERTON SURGICAL CENTER, LP (UNITED STATES) INFORMED COOK ON 25JUL2023 OF AN INCIDENT INVOLVING A NGAGE NITINOL STONE EXTRACTOR (RPN: NGE-017115) FROM AN UNKNOWN LOT. IT WAS REPORTED THAT THE GRASPER DID NOT CLOSE FULLY DURING A URETEROSCOPY PROCEDURE ON AN UNKNOWN DATE. NO ADVERSE EFFECT WERE REPORTED FOR THE PATIENT. ATTEMPTS TO ACQUIRE ADDITIONAL INFORMATION FROM THE USER FACILITY WERE EXECUTED, HOWEVER NO ADDITIONAL INFORMATION WAS PROVIDED TO COOK IN RESPONSE TO THIS INCIDENT. INVESTIGATION ¿ EVALUATION REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL PROCEDURES OF THE DEVICE 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. THE PRODUCT SPECIFICATION FOR THE NGAGE NITINOL STONE EXTRACTOR NGE-017115 WAS REVIEWED, AND 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. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) OR SEARCH FOR OTHER COMPLAINTS FROM THE PRODUCT LOT DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE 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, T_SHEF_REV1; THE IFU DID NOT PROVIDE ANY INFORMATION RELATED TO THE REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, THE NATURE AND CAUSE OF THE ISSUE COULD NOT BE DETERMINED. THERE ARE MULTIPLE POSSIBLE CAUSES FOR THE REPORTED ISSUE OF THE BASKET NOT CLOSING PROPERLY. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. E3- OCCUPATION: MATERIALS MANAGEMENT. 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.

    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 AFTER THE FIRST SUCCESSFUL EXTRACTION DURING AN URETEROSCOPY PROCEDURE THE GRASPER OF AN NGAGE NITINOL STONE EXTRACTOR WOULD NOT FULLY CLOSE. IT WAS NOT CONFIRMED IF OR HOW THE PROCEDURE WAS COMPLETED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707521 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown