BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAIR-PORT WAND

    MDR report key: 6015618 · Received October 10, 2016

    Report

    Report Number
    1717344-2016-00868
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 19, 2016
    Manufacturer
    RF SURGICAL
    Product Code
    LWH
    PMA / PMN Number
    K062642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CONCOMITANT RF DETECT GAUZE, PRODUCT ID (B)(4), WAS RECEIVED FOR EVALUATION. THE INCIDENT WAND (ID: 02-0029) AND THE CONCOMITANT CONSOLE 200E (ID: 01-0030) WERE NOT RETURNED FOR EVALUATION. THE INVESTIGATION CONFIRMED THE REPORTED INCIDENT. VISUAL INSPECTION OF THE GAUZE FOUND NO DEFECTS. THE INVESTIGATION FOUND THAT WHEN THE SINGLE GAUZE WAS SCANNED WITH A WAND (ID 02-0029), THE GAUZE WAS DETECTED. HOWEVER, WHEN THE GAUZE WAS WRAPPED AROUND METAL FORCEPS AND SCANNED WITH THE WAND, THE GAUZE WAS NOT DETECTED. THE INVESTIGATION FOUND THAT THE ROOT CAUSE OF THIS INCIDENT WAS USER ERROR IN WHICH THE USER HAD THE METAL FORCEPS IN THE SCAN AREA CAUSING SCAN INTERFERENCE. THE DIRECTIONS FOR USE (DFU) INSTRUCTS THE USER TO REMOVE METAL OBJECTS FROM THE SCAN AREA AND STATES THAT METAL MAY INTERFERE WITH SCANNING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE INDICATED THAT THE INCIDENT WAND (ID: 02-0029) DEVICE WOULD NOT BE RETURNING FOR EVALUATION. SINCE THE LOT # OF THE INCIDENT DEVICE IS UNKNOWN, A REVIEW OF THE MANUFACTURING NON-CONFORMANCES CANNOT BE COMPLETED. THE SITE INDICATED THAT THE CONCOMITANT CONSOLE 200E (ID: 01-0030) DEVICE WOULD NOT BE RETURNING FOR EVALUATION. A REVIEW OF THE MANUFACTURING NON-CONFORMANCES WAS COMPLETED FOR THIS CONCOMITANT CONSOLE 200E DEVICE AND INDICATES ALL PARAMETERS AND ACCEPTANCE CRITERIA FOR ENTRIES POTENTIALLY PERTINENT TO THE CUSTOMER REPORT WERE WITHIN SPECIFIED LIMITS AT THE TIME OF RELEASE. THE SITE INDICATED THAT THE INCIDENT DEVICE FOR THE CONCOMITANT GAUZE (ID: G0404-16P01C-1) DEVICE WILL BE RETURNING FOR EVALUATION. A REVIEW OF THE MANUFACTURING NON-CONFORMANCES COULD NOT BE COMPLETED FOR THIS CONCOMITANT GAUZE DEVICE BECAUSE THE LOT # IS UNKNOWN. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WAND DID NOT DETECT AN RFID TAGGED GAUZE THAT HAD BEEN ATTACHED TO A CLAMP AND PLACED INSIDE THE SURGICAL AREA OF THE PATIENT. IT WAS IDENTIFIED THAT THE SPONGE WAS NOT DETECTED WHEN THE SPONGE COUNT FOUND THAT THE COUNT WAS OFF. THE STAFF REALIZED THAT THE SPONGE -CLAMP COMBO WAS STILL IN THE PATIENT. THE SPONGE-CLAMP COMBO WAS REMOVED FROM THE PATIENT, SCANNED AGAIN AND STILL NOT DETECTED BY THE WAND. THE SPONGE WAS REMOVED FROM THE CLAMP, SCANNED AND WAS DETECTED BY THE WAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666599 BLAIR-PORT WAND SPONGE DETECTION SYSTEM LWH RF SURGICAL BLAIR-PORT WAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR