BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR TRIPOLAR 90 SUCTION ELECT

    MDR report key: 8443609 · Received March 22, 2019

    Report

    Report Number
    1221934-2019-56662
    Event Type
    Malfunction
    Date Received
    March 22, 2019
    Date of Event
    February 18, 2019
    Report Date
    February 21, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705023103
    PMA / PMN Number
    K143475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY. UDI:(B)(4). INVESTIGATION SUMMARY : THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. THE COMPLAINT CAN BE CONFIRMED. SALINE RESIDUE WAS FOUND INSIDE THE SUCTION TUBING, AND THE FACEPLATE WAS FOUND UNATTACHED WHICH INDICATED THAT THE DEVICE WAS IN USED CONDITION. THE REPORTED ACTIVE METAL TIP BROKEN WAS INVESTIGATED VIA A SUPPLIER CAPA INVESTIGATION (CAP-101220) AND DESIGN AND PROCESS IMPROVEMENTS WERE IMPLEMENTED AS A RESULT. THE MOST PROBABLE ROOT CAUSES FOR THE CAPA FAILURE MODE (SEPARATION OF THE COMPLETE ACTIVE TIP) ARE THE FOLLOWING: THE WELD BRIDGE ON ACTIVE SUCTION TUBE IS NOT PROVIDING SUFFICIENT WELD MATERIAL AND RETENTION. MECHANICAL FATIGUE DUE TO STRESS CORROSION PITTING / CORROSION AND DUE TO WELDING PROCESS MISUSE, (EG. EXTENDED ACTIVATION OR OVERLOADING OF MECHANICAL FORCES) WE CANNOT DETERMINE A SPECIFIC ROOT CAUSE FOR THE FAILURE. THE CAPA HAS BEEN CLOSED DUE TO A NUMBER OF PROCESS IMPROVEMENTS AND DESIGN CHANGES. THE NEW DESIGN FOR THE ACTIVE SUCTION TUBE WAS PROPOSED WITH A WIDER WELD BRIDGE, RAISED SIDE WALLS AROUND THE SUCTION PORT AND A SMALLER SUCTION PORT LENGTH, ALL TO IMPROVE THE MECHANICAL ROBUSTNESS OF THE ACTIVE SUCTION TUBE DESIGN AND TIP RETAINING FUNCTION. THE LOT NUMBER OF THIS DEVICE INDICATED THAT IT WAS MANUFACTURED AFTER THE DESIGN CHANGE WAS IMPLEMENTED. THE DESIGN CHANGE IS INTENDED TO HELP REDUCE THE OCCURRENCE OF THIS FAILURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (PRODUCT : 225028, LOT : U1806119), AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT, NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING AN UNKNOWN SURGERY THE SURGEON NOTICED THE TIP OF THE DEVICE WAS BROKEN RIGHT BEFORE INSERTING IT INTO THE PATIENT'S BODY. THE BROKEN FRAGMENT WAS FOUND ON THE STERILIZED TRAY. THERE WAS NO BROKEN FRAGMENT IN THE PATIENT'S BODY, CONFIRMED UNDER X-RAY. THE SURGEON STARTED THAT THEY HAD NO IDEA WHEN THE DEVICE'S TIP GOT BROKEN. THE DEVICE WAS BRAND NEW AND FIRST USE WHEN THE ISSUE OCCURRED. THE AFFILIATE REPORTED THAT THERE WAS NO PATIENT HARM, BUT THERE WAS NO INFORMATION ON TIME DELAY AVAILABLE. THE AFFILIATE ALSO REPORTED THAT NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238528 VAPR TRIPOLAR 90 SUCTION ELECT ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US U1806119 10886705023103

    Patients

    Seq Age Sex Outcome Treatment
    1