BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS WIRE FLAT WIRE EXTRACTOR

    MDR report key: 17720914 · Received September 11, 2023

    Report

    Report Number
    1820334-2023-01216
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    August 17, 2023
    Report Date
    December 5, 2023
    Manufacturer
    COOK INC
    Product Code
    FFL
    UDI-DI
    00827002327344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    COOK INC. HAS BEEN UNABLE TO SUBMIT REPORTS DUE TO ISSUES WITH RECEIVING NEW SSL CERTIFICATES FOR ESG AS2 TRADING PARTNERS FROM THE ESG HELP DESK. THIS ISSUE WAS DISCOVERED OVER THE WEEKEND OF 25NOV2023. COOK HAS BEEN IN COMMUNICATION WITH THE FDA REGARDING THIS ISSUE AND WAS PROVIDED THE NEEDED SECURITY CERTIFICATE ON 04DEC2023. PER FDA-2008-N-0393, QUESTIONS AND ANSWERS ABOUT EMDR - ELECTRONIC MEDICAL DEVICE REPORTING - GUIDANCE FOR INDUSTRY, USER FACILITIES AND FDA STAFF, SECTION D: ¿¿ IF A MANUFACTURER OR IMPORTER IS UNABLE TO SUBMIT A REPORT ON TIME DUE TO AN OUTAGE AFFECTING THE ESG OR THE CDRH EMDR PROCESSING SYSTEM, IT MAY DOCUMENT ITS ATTEMPTS AT TIMELY FILING IN BLOCK H10 FOR THE AFFECTED REPORTS AND SUBMIT REPORTS ELECTRONICALLY AS SOON AS THE ESG OR CDRH EMDR PROCESSING SYSTEM IS OPERATIONAL.¿ AN EMAIL HAS BEEN SENT TO FDA AS THE GUIDANCE INSTRUCTS INFORMING FDA OF THE INFORMATION SET FORTH IN THE GUIDANCE REGARDING THESE DELAYED SUBMISSIONS. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. EVENT DESCRIPTION: IT WAS REPORTED BY A REPRESENTATIVE OF A VETERINARY HOSPITAL THAT AN ATLAS WIRE FLAT WIRE EXTRACTOR BROKE OFF IN A CANINE OR FELINE PATIENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE. INVESTIGATION ¿ EVALUATION REVIEWS OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), 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 PULL TESTED. 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 IMPORTANT: EXCESSIVE FORCE COULD DAMAGE DEVICE. THE CAUSE FOR THE ISSUE 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. 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 BY A REPRESENTATIVE OF A (B)(6) HOSPITAL THAT AN ATLAS WIRE FLAT WIRE EXTRACTOR BROKE OFF IN A CANINE OR FELINE PATIENT. ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146845 ATLAS WIRE FLAT WIRE EXTRACTOR FFL DISLODGER, STONE, BASKET, URETERAL, METAL FFL COOK INC N/A 15371259 00827002327344

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown