BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCJ

    MDR report key: 5292026 · Received December 12, 2015

    Report

    Report Number
    2027111-2015-00882
    Event Type
    Malfunction
    Date Received
    December 12, 2015
    Report Date
    November 18, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FULL UDI UNKNOWN AS NO MODEL NUMBER AND LOT NUMBER WAS PROVIDED. NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT # HAS BEEN PROVIDED TO MANUFACTURER. A FOLLOW-UP REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE INCIDENT PRODUCT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. THE EXACT ROOT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED, HOWEVER, SIMILAR INCIDENTS IN THE PAST HAVE SHOWN THAT THIS INCIDENT MAY HAVE BEEN DUE TO AN INTERRUPTION IN THE MOLDING PROCESS. APPLIED MEDICAL HAS RECENTLY IMPLEMENTED PROCESS ENHANCEMENTS INTENDED TO MINIMIZE THE POTENTIAL FOR THIS TYPE OF INCIDENT TO OCCUR DURING THE MANUFACTURING PROCESS. WE APOLOGIZE FOR ANY INCONVENIENCE THIS MAY HAVE CAUSED AND ASSURE YOU THAT 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.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED UNKNOWN. "PATIENT WAS SUFFERING FROM ABDOMINAL PAIN. DR (B)(6) INITIATED A SCANNER WHICH REVEALED A FOREIGN OBJECT IN THE ABDOMEN. OBJECT WAS REMOVED AND APPEARED TO BE A PIECE OF THE DISTAL PART OF A TROCAR SHOWING THE WORD APPLIED. THE OBJECT WAS GIVEN TO THE PATIENT UNDER HER REQUEST. SHE INDICATED TO THE DOCTOR THAT SHE HAS PREVIOUSLY BEEN OPERATED IN HOSPITAL (B)(6). DATE AND NAME OF PROCEDURE IN (B)(6) ARE UNKNOWN. DR (B)(6) WILL DECLARE THIS INCIDENT TO ANSM NO PICTURE AVAILABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821427 GCJ GCJ APPLIED MEDICAL UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R