BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN COBLATOR II SURGERY SYSTEM AND WAND

    MDR report key: 19144407 · Received April 19, 2024

    Report

    Report Number
    3006524618-2024-00155
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    August 9, 2023
    Report Date
    May 21, 2024
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE LIMITED CLINICAL INFORMATION PROVIDED. INSUFFICIENT PRODUCT IDENTIFICATION INFORMATION WAS PROVIDED AND THUS A MANUFACTURING RECORD REVIEW, COMPLAINT HISTORY REVIEW, INSTRUCTION FOR USE REVIEW, RISK MANAGEMENT REVIEW, COULD NOT BE CONDUCTED. BASED ON THE INFORMATION AVAILABLE, THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A CLINICAL REVIEW STATES THAT BASED ON THE LIMITED INFORMATION PROVIDED, IT IS UNKNOWN IF THE IFU FOR THE COBLATOR WAS ADHERED TO. THE PATIENT IMPACT BEYOND THE REPORTED SURGICAL REPAIR AND ADMISSION FOR SUBSEQUENT CARE AND MONITORING COULD NOT BE CONFIRMED NOR CONCLUDED SINCE THE PATIENT¿S OUTCOME IS UNKNOWN. BASED ON THE LIMITED INFORMATION PROVIDED WE ARE UNABLE TO CONCLUDE ON FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED REPORT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. H11: H2: CORRECTED DATA ON H6 (HEALTH EFFECT - CLINICAL CODE & HEALTH EFFECT - IMPACT CODE).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A TONSILLECTOMY USING A FOOT PEDAL WITH A COBLATOR II CONTROLLER, A PATIENT'S ARTERIES WERE MISTAKENLY CUT, WHICH RESULTED IN SIGNIFICANT BLEEDING, IMMEDIATE CONSULT, SURGICAL REPAIR BY VASCULAR SURGERY AND ADMISSION FOR SUBSEQUENT CARE AND MONITORING. THE BLEED THAT THE PATIENT EXPERIENCED WAS THE RESULT OF ACCIDENTALLY STEPPING ON THE WRONG FOOT PEDAL OF THE SURGICAL TOOL. IT IS UNKNOWN IF A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE AND IF THERE WAS ANY SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082407 UNKN COBLATOR II SURGERY SYSTEM AND WAND ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male Required Intervention| O