BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUSNARE POLYPECTOMY SNARE SOFT

    MDR report key: 2230999 · Received August 26, 2011

    Report

    Report Number
    1037905-2011-00566
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K851958
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: OUR EVAL OF THE DEVICE SAID TO BE INVOLVED DID NOT CONFIRM THE REPORT BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVAL. THE DEVICE HAS BEEN CUT APPROX 55 CENTIMETERS FROM THE DISTAL END OF THE HANDLE. THE CATHETER HAS BUCKLED AT THE DISTAL END OF THE HANDLE. THE KINK IN THE OUTER CATHETER SUGGESTS EXCESSIVE PRESSURE HAD BEEN APPLIED TO THE SNARE. WE WERE UNABLE TO DETERMINE EXACTLY WHEN THE OUTER CATHETER BECAME KINKED. A VISUAL EXAMINATION OF THE ELECTRICAL PIN INSIDE THE ACUSNARE HANDLE ASSEMBLY CONFIRMED THE COMPONENTS ARE APPROPRIATE (I.E. NO BENDS ARE PRESENT). A CONDUCTIVITY TEST WAS PERFORMED ON THE PARTIAL DEVICE THAT WAS RETURNED. THE CHECK WAS TO VERIFY IF CURRENT WAS PRESENT ON THE EXISTING DRIVE WIRE. NO CURRENT WAS PRESENT WHEN THE ELECTROSURGICAL GENERATOR WAS ACTIVATED. THIS COULD BE DUE TO THE CONDITION OF THE OUTER CATHETER BEING BUCKLED AT THE HANDLE. 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. CONCLUSIONS: A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED BECAUSE THE CONDITION OF THE PRODUCT SAID TO BE INVOLVED PROHIBITED A COMPLETE EVAL. 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 MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY, THE PHYSICIAN SELECTED A COOK ACUSNARE POLYPECTOMY SNARE SOFT. THE PHYSICIAN ADVANCED THE SNARE THROUGH THE ENDOSCOPE AND INTO POSITION. THE SNARE WAS EXTENDED FROM THE OUTER CATHETER AND PLACED AROUND WHAT WAS DESCRIBED TO BE A LARGE POLYP, APPROX 4CM IN SIZE. THE SNARE DEVICE REPORTEDLY WOULD NOT HEAT TO CAUTERIZE. THE MEDICAL STAFF TURNED THE ELECTROSURGICAL UNIT SETTINGS UP TO 40 AT DIFFERENT INTERVALS BUT WHEN APPLYING THE ELECTRICITY, NOTHING HAPPENED. THE ACTIVE CORD THAT CONNECTS THE SNARE TO THE ELECTROSURGICAL UNIT WAS REPLACED BUT AGAIN, NOTHING HAPPENED. THE PHYSICIAN DECIDED TO REMOVE AND REPLACE THE SNARE DEVICE. WHEN ATTEMPTING TO REMOVE THE SNARE FROM THE PT, IT WOULD NOT MOVE AND SEEMED TO BE STUCK. A SECOND PHYSICIAN ENTERED THE PROCEDURE ROOM IN AN ATTEMPT TO ASSIST REMOVING THE SNARE BUT WAS ALSO UNSUCCESSFUL. THE PHYSICIAN CUT THE OUTER CATHETER IN AN ATTEMPT TO REMOVE THE SNARE BUT THIS WAS UNSUCCESSFUL. THE PHYSICIAN THEN DECIDED TO CUT THE SNARE DRIVE WIRE NEAR THE HANDLE BUT THIS DID NOT FACILITATE REMOVAL OF THE SNARE FROM THE PT. AT THIS TIME, THE SNARE WIRE WAS REPORTEDLY PULLING ON THE POLYP TIGHTLY CAUSING A CONCERN FOR PERFORATION. THEREFORE, THE PT WAS TRANSFERRED TO THE HOSP. A RIGHT HEMICOLECTOMY WAS PERFORMED TO REMOVE THE SNARE DEVICE. THE PHYSICIAN ARRANGED FOR A PATHOLOGIST TO VERIFY IF ANY SIGNS OF BURNING OR CAUTERIZATION HAD OCCURRED. THE PATHOLOGIST EXAMINED SOME TISSUE SAMPLES AND INDICATED THERE WERE NO SIGNS OF BURNING OR CAUTERIZATION. TWO (2) DAYS AFTER THE PROCEDURE, THE PT IS WALKING AROUND AND RECOVERING. THE PHYSICIAN EXPECTS A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUSNARE POLYPECTOMY SNARE SOFT KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC W2996473

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R ACTIVE CORD (UNK TYPE)| OLYMPUS ENDOSCOPE (UNK TYPE)| OLYMPUS ESG-100 ELECTROSURGICAL UNIT