BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICKSILVER BIPOLAR COAGULATION PROBE

    MDR report key: 2031077 · Received March 16, 2011

    Report

    Report Number
    1037905-2011-00146
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 14, 2011
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    KNS
    PMA / PMN Number
    K990145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED TO COOK FOR EVAL ON (B)(4) 2011. THE PRODUCT WAS RETURNED TO OUR APPROVED PROBE SUPPLIER FOR EVAL. WE HAVE NOT YET RECEIVED THE EVAL RESULTS FROM THE APPROVED SUPPLIER. A F/U MDR WILL BE SUBMITTED ON OR BEFORE(B)(4) 2011. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. A REVIEW OF THE 12 MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. THIS REPORT REPRESENTS AN UNUSUAL OCCURRENCE. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. PRODUCT RETURNED TO SUPPLIER FOR EVAL. CONCLUSIONS: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LAB SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LAB ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. TIP BREAKAGE CAN OCCUR IF THE TIP COMES INTO CONTACT WITH A HARD SURFACE DURING USE AND/OR GENERAL HANDLING. BREAKAGE OF THE PROBE TIP CAN OCCUR IF THE DISTAL END OF THE ENDOSCOPE IS DEFLECTED MORE THAN 15 DEGREES WHEN THE BIPOLAR PROBE IS ADVANCED OR WITHDRAWN FROM THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE INSTRUCTIONS FOR USE WARN THE USER NOT TO PASS THE PROBE THROUGH AN ENDOSCOPE WHOSE DISTAL END IS DEFLECTED AT AN ANGLE MORE THAN APPROX 15 DEGREES. PRIOR TO DISTRIBUTION, ALL COOK ENDOSCOPY QUICKSILVER BIPOLAR PROBES ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THIS OBSERVATION REPRESENTS AN UNUSUAL OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING ENDOSCOPIC CAUTERIZATION OF A GASTRIC BLEED, THE PHYSICIAN USED A COOK QUICKSLIVER BIPOLAR COAGULATION PROBE. DURING USE OF THE PROBE, THE DISTAL TIP DETACHED IN THE ENDOSCOPE. THE ENDOSCOPE WAS REMOVED FROM THE PT AND THE TIP WAS FLUSHED OUT OF THE ENDOSCOPE. THE TIP WAS DISCARDED AT THE USER FACILITY. ANOTHER PROBE WAS USED TO COMPLETE THE PROCEDURE. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSILVER BIPOLAR COAGULATION PROBE KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL, INC. W2932636

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OLYMPUS GIF-N180 ENDOSCOPE