BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1221934-2018-50961

    MDR report key: 7655004 · Received July 2, 2018

    Report

    Report Number
    1221934-2018-50961
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE WAS RECEIVED AND REVIEWED TOGETHER WITH AN ENGINEER. VISUAL OBSERVATION CONFIRMS THAT THE SPRING WAS MISSING ON THE BRIDGE. THE BODY WAS INTACT AND NO ANOMALIES WERE FOUND. THIS DEVICE NEEDS TO BE DISASSEMBLED FOR CLEANING AFTER EACH USE. IT IS POSSIBLE THAT THE DEVICE WAS NOT PROPERLY REASSEMBLED AFTER CLEANING OR REPEATED USE AND CLEANING CYCLES RESULTED IN THE PARTS LOOSENING UP AND COMING APART. OTHER THAN THESE POSSIBILITIES, WE CANNOT DISCERN A ROOT CAUSE FOR THIS FAILURE MODE. A BATCH RECORD REVIEW HAS BEEN CONDUCTED TO DETERMINE IF THERE WERE ANY INTERNAL PROCESSING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THE NATURE OF THE PRODUCT COMPLAINT. OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. FURTHER, A REVIEW INTO THE DEPUY MITEK COMPLAINTS SYSTEM REVEALED TWO OTHER SIMILAR COMPLAINTS FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. BASED ON THE OVERALL COMPLAINT RATE AND CUSTOMER IMPACT, NO FURTHER CORRECTIVE ACTION IS WARRANTED AT THIS TIME. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. THIS REPORT IS BEING FILED FROM THE REMETREX COMPLAINT MANAGEMENT SYSTEM AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY OUR AFFILIATE PARTS OF THE BRIDGE CAME APART AND SMALL SPRING WAS LOST OF THE X-PLORE DEVICE AND THE SHEATH COULDN'T BE USED ANYMORE. THIS HAPPENED BEFORE USE ON THE PATIENT. THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED WITH A LIKE DEVICE. NO PATIENT HARM OR CLINICALLY RELEVANT INCREASE IN PROCEDURE DURATION REPORTED. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50962.

    Patients

    Seq Age Sex Outcome Treatment
    1