BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGAGE NITINOL STONE EXTRACTOR

    MDR report key: 17571291 · Received August 18, 2023

    Report

    Report Number
    1820334-2023-01103
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 27, 2023
    Report Date
    November 2, 2023
    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

    INVESTIGATION: EVALUATION. A REPRESENTATIVE OF HANGZHOU QIANSHENGHUI TECHNOLOGY CO.,LTD (CHINA) INFORMED COOK ON (B)(6) 2023 OF AN INCIDENT INVOLVING A NGAGE NITINOL STONE EXTRACTOR (RPN: NGE-017115) FROM LOT # 14879075. IT WAS REPORTED THAT THE DEVICE WOULD NOT OPEN DURING A LITHOTRIPSY AND KIDNEY STONE REMOVAL PROCEDURE ON (B)(6) 2023. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT REPORTEDLY EXPERIENCED NO HARM AS A RESULT OF THE ISSUE. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES OF THE DEVICE, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST, WERE CONDUCTED DURING THE INVESTIGATION. ONE DEVICE WAS RETURNED TO COOK IN OPEN PACKAGING. THE HANDLE ACTUATES BASKET FORMATION BUT WILL NOT FULLY OPEN THE BASKET. THE RETURNED DEVICE WAS FOUND TO HAVE A BASKET THAT WAS SEVERELY MISSHAPED DUE TO DAMAGE TO THE BASKET COMPONENTS. THE BASKET SHEATHS (SHRINK TUBE) THAT HOLD THE BASKET WIRES IN PLACE WERE SPLIT, PREVENTING THE BASKET FROM FORMING THE PROPER SHAPE WHEN OPENED. THERE WAS DEBRIS ON TIP OF FORMATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT THE DEVICE HISTORY RECORD FOR LOT# 14879075 WAS REVIEWED AND THERE WERE NO RELATED NON CONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS HAD BEEN REPORTED FROM THE COMPLAINT DEVICE LOT. 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. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, 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 PROVIDES THE FOLLOWING INFORMATION: SUGGESTED HANDLING INSTRUCTIONS FOR EXTRACTORS AND FORCEPS IMPORTANT: EXCESSIVE FORCE COULD DAMAGE DEVICE. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE THAT PROCEDURAL FACTORS SUCH AS THE SIZE, SHAPE, AND LOCATION OF THE STONE CAUSED THE DAMAGE. HOWEVER, NO PROCEDURAL FACTORS RELATED TO THE PROCEDURE ARE KNOWN. 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. E1- CUSTOMER (PERSON): PHONE: (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 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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 AN NGAGE NITINOL STONE EXTRACTOR WOULD NOT OPEN. DURING A KIDNEY STONE REMOVAL PROCEDURE FOR A MALE PATIENT, THE USER WAS UNABLE TO OPEN THE BASKET PROPERLY. THE PROCEDURE WAS COMPLETED WITH A NEW SAME DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330315 NGAGE NITINOL STONE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC N/A 14879075 10827002482941

    Patients

    Seq Age Sex Outcome Treatment
    1 Male ANQING ENDOSCOPE