BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 6456134 · Received April 4, 2017

    Report

    Report Number
    1037905-2017-00141
    Event Type
    Injury
    Date Received
    April 4, 2017
    Date of Event
    February 6, 2017
    Report Date
    April 3, 2017
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KGE
    PMA / PMN Number
    K000086
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): OR K923470. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: 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 HOT FORCEPS ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PROVIDED TO COOK VIA MEDWATCH REPORT MW5067966: "FORCEP WOULD NOT CLOSE WHILE REMOVING THE TISSUE FOR BIOPSY DURING THE UPPER GI ENDOSCOPY." PER THE RECEIVED MEDWATCH REPORT, A SERIOUS INJURY OCCURRED, AND REQUIRED INTERVENTION WAS PERFORMED. THERE WERE NO OTHER DETAILS INCLUDED ON THE MEDWATCH REPORT. MULTIPLE ATTEMPTS TO DETERMINE THE CUSTOMER OR OTHER DETAILS RELATED TO THIS EVENT WERE COMPLETED WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238508 UNKNOWN KGE, FORCEPS, BIOPSY, ELECTRIC KGE COOK ENDOSCOPY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention