BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR COOLPULSE90 ELECTRODE

    MDR report key: 8275963 · Received January 24, 2019

    Report

    Report Number
    1221934-2018-51395
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Report Date
    March 23, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705010080
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    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. THIS REPORT IS BEING FILED FROM THE (B)(4) AS REQUIRED UNDER MITEK'S CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) TO FILE USA FDA MDR MISSED MALFUNCTIONS. (B)(4). FOUR COMPLAINT DEVICES WERE RECEIVED FOR EVALUATION. THERE WERE TWO DEVICES ON THIS COMPLAINT AND TWO ON (B)(4). THE FOUR DEVICES WERE ALL IN THE SAME PACKAGE AND THERE WAS NO IDENTIFICATION AS TO THE LOT NUMBERS OF THE DEVICES. VISUAL OBSERVATION DOES NOT INDICATE ANY ANOMALIES ON THE DEVICE. THERE IS SOME DISCOLORATION OBSERVED UNDER MAGNIFICATION ON THE TIP. INFORMATION FROM THE SUPPLIER INDICATES THAT THIS DISCOLORATION IS AS A RESULT OF ACTIVATION OF THE DEVICE IN A SALINE SOLUTION. THE RESULT OF THIS ACTIVATION MAY RESULT IN THE DISCOLORATION ON THE ACTIVE TIP OF THE DEVICE AND IS CONSIDERED NORMAL. ALL ELECTRODES HAVE A FUNCTIONAL FINAL TEST PERFORMED BY THE SUPPLIER IN A SALINE SOLUTION BEFORE BEING SHIPPED TO THE CUSTOMERS. WE BELIEVE THIS TO BE ANOMALY AND A ONE OFF INCIDENT. THIS COMPLAINT CANNOT BE CONFIRMED. A DHR REVIEW FOR LOT NUMBER U151127 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 SYNTHES MITEK COMPLAINTS SYSTEM FOR LOT NUMBER U151127 REVEALED ONE SIMILAR COMPLAINT ((B)(4)) FOR THIS LOT OF (B)(4) DEVICES THAT WERE RELEASED TO DISTRIBUTION. FOR LOT NUMBER U1511062, THERE WERE NO COMPLAINTS OF ANY TYPE FOR THIS LOT OF DEVICES. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A SUBACROMIAL DECOMPRESSION, THE TIP OF THE ELECTRODE WAS IDENTIFIED TO BE RUSTY. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT WITH TWO MINUTE DELAY. THIS IS REPORT 2 OF 2 FOR 1221934-2018-51387.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67879 VAPR COOLPULSE90 ELECTRODE ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE USE GEI DEPUY MITEK LLC US U1511062 10886705010080

    Patients

    Seq Age Sex Outcome Treatment
    1