BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIDER2 24V BATTERY CHARGER

    MDR report key: 10151549 · Received June 14, 2020

    Report

    Report Number
    1643264-2020-00368
    Event Type
    Malfunction
    Date Received
    June 14, 2020
    Date of Event
    May 21, 2020
    Report Date
    November 3, 2020
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MOK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT FACILITY FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. NO PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. A COMPLAINT HISTORY REVIEW FOUND RELATED FAILURES. THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION WAS PERFORMED ON THE PRODUCT AND NO ISSUES WERE OBSERVED. A FUNCTIONAL EVALUATION REVEALED THE DEVICE'S INDICATOR DIODE WOULD NOT CHANGE TO CHARGING MODE WHEN A TEST BATTERY WAS INSTALLED. THE FUSE WAS CHECKED BY AN OHMMETER AND WAS OPEN. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE IS A BLOWN FUSE. NO PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW COULD NOT BE CONDUCTED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPIDER'S BATTERY CHARGER WAS NOT CHARGING THE BATTERY. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615435 SPIDER2 24V BATTERY CHARGER VAGINOSCOPE AND ACCESSORIES MOK SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1