BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCJ

    MDR report key: 5307198 · Received December 17, 2015

    Report

    Report Number
    2027111-2015-00898
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    November 12, 2015
    Report Date
    November 19, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER, HOWEVER, NO RESPONSE WAS RECEIVED. INVESTIGATION SUMMARY: WE HAVE TRIED TO OBTAIN THE INCIDENT DEVICE FOR EVALUATION WITH NO SUCCESS. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED AS THE CUSTOMER WAS UNABLE TO PROVIDE THE MODEL OR LOT NUMBER OF THE DEVICE. ALTHOUGH THE EXACT ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED, APPLIED MEDICAL HAS RECEIVED REPORTS OF SIMILAR ISSUES AND HAS OPENED A CORRECTIVE AND PREVENTATIVE ACTION REPORT TO FURTHER ELEVATE AND TRACK THIS INVESTIGATION AND IMPLEMENT APPROPRIATE CORRECTIVE ACTIONS TO MITIGATE THIS TYPE OF INCIDENT. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS TO FOLLOW UP WITH MW5058077.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: MODEL TO BE DETERMINED UPON PRODUCT RETURNED. THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS TO FOLLOW UP WITH MEDWATCH# MW5058077.

    Description of Event or Problem · 1

    ROBOTIC GASTRIC BYPASS AND CHOLECYSTECTOMY - "A BLACK CIRCLE WAS NOTICED IN THE SURGICAL FIELD AND WAS REMOVED BY THE ASSIST SURGEON. THE BLACK PIECE MATCHED A MISSING AREA ON THE TROCAR, SO THE WHOLE ITEM WAS REMOVED AND REPLACED. IT IS BELIEVED THAT ALL PIECES WERE REMOVED FROM THE PATIENT AND THERE WAS NO PATIENT HARM." PATIENT STATUS- DISCHARGED. MEDWATCH REPORT: VOLUNTARY 25-NOV-2015 07:27:42:00: "A BLACK CIRCLE WAS NOTICED IN THE SURGICAL FIELD AND WAS REMOVED BY THE ASSISTING SURGEON. THE BLACK PIECE MATCHED THE MISSING AREA FROM A TROCAR. ALL PIECES ARE BELIEVED TO HAVE BEEN REMOVED FROM THE PT. THE TROCAR WAS REMOVED AND REPLACED. NO PT HARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835014 GCJ GCJ APPLIED MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1