BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPE STAINLESS STEEL MANDRIL WIRE GUIDE

    MDR report key: 6055273 · Received October 25, 2016

    Report

    Report Number
    1820334-2016-01213
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 20, 2016
    Report Date
    March 3, 2025
    Manufacturer
    COOK INC
    Product Code
    DXQ
    UDI-DI
    00827002051775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. D. 2) DQX WIRE, GUIDE, CATHETER. INVESTIGATION - EVALUATION: THE CUSTOMER REPORTED, "BREAKAGE OF THE TIP END OF THE CUTTING WIRE DURING A PERCUTANEOUS NEPHRECTOMY G, USED WITH A DRAINAGE PERCUTANEOUS HUISMAN'S PROBE - J 7.5F (MERIT). PRODUCT DISCARDED." A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS AND QUALITY CONTROL WAS 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 DEVICE HISTORY RECORD WAS CONDUCTED; THE LOT MET ALL FINISHED GOODS RELEASE CRITERIA. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. NO PRODUCT WAS RETURNED TO AID IN THE INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR FAILURE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS, AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL MITIGATION ACTIVITY IS REQUIRED AT THIS TIME. H3 OTHER TEXT : BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. D. 2) DQX WIRE, GUIDE, CATHETER. INVESTIGATION - EVALUATION: THE CUSTOMER REPORTED, "BREAKAGE OF THE TIP END OF THE CUTTING WIRE DURING A PERCUTANEOUS NEPHRECTOMY G, USED WITH A DRAINAGE PERCUTANEOUS HUISMAN'S PROBE - J 7.5F (MERIT). PRODUCT DISCARDED." A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS AND QUALITY CONTROL WAS 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 DEVICE HISTORY RECORD WAS CONDUCTED; THE LOT MET ALL FINISHED GOODS RELEASE CRITERIA. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. NO PRODUCT WAS RETURNED TO AID IN THE INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR FAILURE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS, AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL MITIGATION ACTIVITY IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED RETROSPECTIVELY PER FDA REQUEST. ALL INFORMATION FOR THIS EVENT WAS PREVIOUSLY SUBMITTED FROM 25OCT2016-03FEB2017.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS NEPHRECTOMY PROCEDURE. DURING THE PROCEDURE IT WAS NOTICED THAT THE TIP END OF THE CUTTING WIRE HAD BROKEN. THE PRODUCT WAS DISCARDED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706276 COPE STAINLESS STEEL MANDRIL WIRE GUIDE DQX WIRE, GUIDE, CATHETER DXQ COOK INC N/A 00827002051775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown