BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN COBLATION ENT DEV

    MDR report key: 18217433 · Received November 28, 2023

    Report

    Report Number
    3006524618-2023-00473
    Event Type
    Injury
    Date Received
    November 28, 2023
    Date of Event
    August 1, 2018
    Report Date
    December 28, 2023
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    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, RISK MANAGEMENT REVIEW, AND AN INSTRUCTIONS FOR USE/DEVICE LABELING 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 INFORMATION PROVIDED, THE LIKELY CAUSE OF THE REPORTED PTH ONE-WEEK POST-PROCEDURE WAS LIKELY DUE TO DIET NON-COMPLIANCE. ACCORDING TO THE REPORT, THIS ADVERSE EVENT WAS TREATED BY A SURGICAL INTERVENTION TO CONTROL THE BLEEDING. THE PATIENT IMPACT BEYOND THE PTH AND THE SURGICAL INTERVENTION CANNOT BE DETERMINED SINCE THE PATIENT¿S OUTCOME WAS NOT REPORTED DURING HER LAST EVALUATION PERFORMED IN JULY 2021. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE WEEK AFTER AN INTRACAPSULAR TONSILLECTOMY AND ADENOIDECTOMY, WITH A COBLATION WAND, PATIENT PRESENTED TO ED WITH 3.5 HOURS OF BLEEDING FROM MOUTH. PATIENT WAS DOING WELL POST-OPERATIVELY, PAIN CONTROLLED, AND WAS TOLERATING A REGULAR DIET. AT 2PM THAT DAY, PATIENT ATE AN ENTIRE HOT POCKET WITHOUT ISSUE. AT 4PM, PATIENT BEGAN TO HAVE SLOW STEADY BLEEDING FROM MOUTH. BY THE TIME SHE PRESENTED TO ED AN HOUR LATER, BLEEDING STOPPED. THERE WAS A LARGE CLOT OVERLYING RIGHT TONSILLAR FOSSA. WHEN PATIENT SPAT CLOT OUT, BLEEDING RESUMED. PATIENT ADMITTED TO OR FOR CONTROL OF PTH WITH ENT. NO OUTCOMES REPORTED AT LAST EVALUATION PERFORMED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1545321 UNKN COBLATION ENT DEV ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Female Other