BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCISE XP COBLATOR II

    MDR report key: 11319178 · Received February 11, 2021

    Report

    Report Number
    3006524618-2021-00174
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    November 20, 2020
    Report Date
    March 20, 2021
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    UDI-DI
    00817470000368
    PMA / PMN Number
    K202006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10 H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS RECEIVED FOR EVALUATION. THERE WAS NO RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION OF THE RETURNED INSTRUMENT SHOWS NO MANUFACTURING ABNORMALITIES. NO VISUAL ISSUES WERE OBSERVED. THE DEVICE WAS PLUGGED INTO THE CONTROLLER AND REGISTERED SETTINGS (7,3). THE WAND WAS ABLE TO GENERATE PLASMA AS INTENDED. A REVIEW OF THE CUSTOMER PROVIDED IMAGE SHOWS THE PACKAGING AND CONFIRMS PART NUMBER EIC8872-01 AND LOT NUMBER 2021094. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS AN ISOLATED EVENT. THE COMPLAINT WAS NOT VERIFIED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. 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.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE-(B)(4). B5: UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING TONSILLECTOMY AND ADENOIDECTOMY SURGERY, THE "PROCISE XP WAND" COULD NOT FORM PLASMA. THE CONTROLLER INDICATED THE WAND IS ACTIVATED WITH AUDIBLE TONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING TONSILLECTOMY AND ADENOIDECTOMY SURGERY, THE "PROCISE XP WAND" COULD NOT FORM PLASMA. THE CONTROLLER INDICATED THE WAND IS ACTIVATED WITH AUDIBLE TONE. ALTHOUGH A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE, IT IS UNKNOWN IF THERE WAS A SURGERY DELAY. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. 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
    214738 PROCISE XP COBLATOR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORP. EIC8872-01 2021094 00817470000368

    Patients

    Seq Age Sex Outcome Treatment
    1