BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUSNARE POLYPECTOMY SNARE

    MDR report key: 2202206 · Received August 4, 2011

    Report

    Report Number
    1037905-2011-00512
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 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
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: AS PART OF THIS COMPLAINT INVESTIGATION, SEVERAL REQUESTS FOR RETURN OF THE PRODUCT FOR EVALUATION HAVE BEEN CARRIED OUT. THE PRODUCT SAID TO BE INVOLVED HAS NOT ARRIVED AT COOK FOR EVALUATION. THEREFORE, A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT AND THE REPORT COULD NOT BE CONFIRMED. IF THE PRODUCT ARRIVES AT A LATER DATE, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE DEVICE HISTORY RECORD AND SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. AFTER A REVIEW OF THE ACCOUNT ORDERING AND SHIPPING HISTORY, THE LOT NUMBER INVOLVED COULD NOT BE DETERMINED. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. PRIOR TO DISTRIBUTION ALL ACUSNARE DEVICES ARE SUBJECTED TO A FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. 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 REMOTE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ENDOSCOPY PROCEDURE, THE PHYSICIAN USED A COOK ACUSNARE POLYPECTOMY SNARE. THE SNARE REPORTEDLY SNAPPED WHILE INSIDE THE PATIENT. THE SNARE WAS RETRIEVED FROM THE PATIENT. SEVERAL ATTEMPTS WERE MADE IN AN ATTEMPT TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT IMPACT AND PRODUCT USAGE. THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACTIVE CORD (UNKNOWN TYPE)| ENDOSCOPE (UNKNOWN TYPE)| ELECTROSURGICAL UNIT (UNKNOWN TYPE)