BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSA FIRM URETERAL STENT SET

    MDR report key: 8737582 · Received June 26, 2019

    Report

    Report Number
    1820334-2019-01525
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    May 8, 2019
    Report Date
    July 29, 2019
    Manufacturer
    COOK INC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL DATA, AND SPECIFICATIONS 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 THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF PRODUCTION PROCESSES AND QUALITY INSPECTION DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE LOT NUMBER IS UNKNOWN, A REVIEW OF THE DEVICE HISTORY RECORD AND A SEARCH FOR ADDITIONAL COMPLAINTS ON THE SAME LOT COULD NOT BE PERFORMED. THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: CAUTIONS: DO NOT FORCE COMPONENTS DURING REMOVAL OR REPLACEMENT. CAREFULLY REMOVE THE COMPONENTS IF ANY RESISTANCE IS ENCOUNTERED. THE CAUSE OF THE COMPLAINT COULD NOT BE ESTABLISHED. THE COMPLAINT WAS CONFIRMED BASED ON THE CUSTOMER¿S TESTIMONY. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED. THE APPROPRIATE INTERNAL 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.

    Description of Event or Problem · 0

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    PMA/510K #: K161236. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED DURING KIDNEY/URETER STENT PLACEMENT USING A UNIVERSA FIRM URETERAL STENT SET, THE "STRING LOOSENS AT THE SLIGHTEST TOUCH." THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES AS A RESULT OF THIS OCCURRENCE. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. FURTHER EVENT DETAILS WERE OBTAINED: IT WAS REPORTED, WHILE POSITIONING THE STENT, THE TETHER BROKE. THE STENT WAS WHERE IT NEEDED TO BE AND WAS LEFT IN THE PATIENT. THE TETHER WAS REMOVED WITH FORCEPS. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527375 UNIVERSA FIRM URETERAL STENT SET FAD STENT, URETERAL FAD COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1