BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 1812437 · Received August 12, 2010

    Report

    Report Number
    1037905-2010-00372
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Report Date
    July 14, 2010
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    PMA / PMN Number
    K851958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: WE COULD NOT CONFIRM THE REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED TO COOK ENDOSCOPY FOR EVAL. AFTER A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED, WE CAN REPORT NO DISCREPANCIES OR ANOMALIES WERE OBSERVED. WE WERE UNABLE TO CONDUCT A SAMPLE TEST FROM THIS LOT BECAUSE NONE OF THE PRODUCTS FROM THIS LOT REMAINED IN FINISHED GOODS INVENTORY. A REVIEW OF THE TWELVE MONTH COMPLAINT HISTORY FOR THIS PRODUCT FAMILY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS REMOTE. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE FOR THE ACUSNARE DIRECT THE USER TO INSPECT THE ACTIVE CORD PRIOR TO USE. THE INSTRUCTIONS INDICATE THE ACTIVE CORD MUST BE FREE OF KINKS, BENDS, BREAKS AND EXPOSED WIRES TO ALLOW FOR ACCURATE TRANSFER OF CURRENT. IF AN ABNORMALITY IS NOTED, THE INSTRUCTIONS DIRECT THE USER NOT TO USE THE ACTIVE CORD. USING A COMPROMISED ACTIVE CORD WITH THE ACUSNARE COULD HAVE CAUSED THE REPORTED DIFFICULTY WITH CURRENT APPLICATION. BEFORE USING THE ACUSNARE, THE INSTRUCTIONS FOR USE INSTRUCT THE USER TO SECURELY CONNECT THE ACTIVE CORD TO THE DEVICE HANDLE AND ELECTROSURGICAL UNIT. THE INSTRUCTIONS ADVISE THE USER THAT THE ACTIVE CORD FITTINGS SHOULD FIT SNUGLY INTO BOTH THE DEVICE HANDLE AND THE ELECTROSURGICAL UNIT. AN INSECURE CONNECTION COULD CONTRIBUTE TO DIFFICULTY WITH CURRENT APPLICATION. PRIOR TO DISTRIBUTION, ALL ACUSNARE POLYPECTOMY SNARES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. 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 FURTHER ACTION IS WARRANTED AT THIS TIME. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS REMOTE. CUSTOMER QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A BIOPSY PROCEDURE, THE PHYSICIAN USED A COOK ENDOSCOPY ACUSNARE POLYPECTOMY SNARE. THE SNARE WAS ADVANCED INTO POSITION AND WOULD NOT CAUTERIZE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADDITIONAL 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 ACUSNARE POLYPECTOMY SNARE KNS, SNARE, FLEXIBLE KNS COOK ENDOSCOPY W2856604

    Patients

    Seq Age Sex Outcome Treatment
    1 ACTIVE CORD (UNK TYPE)| OLYMPUS ENDOSCOPE (SPECIFIC MODEL # NOT PROVIDED)| VALLEY LAB FORCE FX ELECTROSURGICAL GENERATOR UNIT