BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAPR3 GENERATOR *EA

    MDR report key: 8290561 · Received January 30, 2019

    Report

    Report Number
    1221934-2019-56279
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    July 20, 2016
    Report Date
    August 22, 2016
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    GEI
    UDI-DI
    10886705009107
    PMA / PMN Number
    K113545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 DEFECT HAS BEEN VERIFIED AND REPAIRED. THE FOLLOWING REPAIR ACTIVITIES WERE PERFORMED REPLACED LOOM - CPU TO VFD, GA,ELECTRICAL SAFETY AND RELEASE TESTS. A REVIEW INTO THE DEPUY SYNTHES MITEK COMPLAINTS SYSTEM REVEALED ONE OTHER SIMILAR COMPLAINT FOR THIS DEVICE'S SERIAL NUMBER. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND 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. DHR REVIEW: PART NUMBER: 225021. SUPPLIER LOT NUMBER: 1221854. RELEASE TO WAREHOUSE DATE: 11/15/12. MANUFACTURING DATE: 11/15/12. EXPIRATION DATE: N/A. SUPPLIER: (B)(4). MANUFACTURING SITE: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VAPR3 GENERATOR WAS GENERATING AN ERROR. THIS DID NOT OCCUR DURING SURGERY. THERE ARE NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84327 VAPR3 GENERATOR *EA ELECTROSURGICAL SYSTEM GENERATOR GEI DEPUY MITEK LLC US 10886705009107

    Patients

    Seq Age Sex Outcome Treatment
    1