BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN COBLATION ENT DEV

    MDR report key: 18186071 · Received November 21, 2023

    Report

    Report Number
    3006524618-2023-00448
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    February 1, 2018
    Report Date
    December 28, 2023
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K202006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: 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. 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. H2: CORRECTED DATA ON: H6: (HEALTH EFFECT: IMPACT CODE).

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: CASE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 DAYS AFTER AN INTRACAPSULAR TONSILLECTOMY AND ADENOIDECTOMY WITH A COBLATION WAND, PATIENT PRESENTS TO ED WITH BLOODY EMESIS. PATIENT VOMITED BLOOD AND LOST 400ML OF BLOOD AND PASSED OUT WHILE AT HOME AND LOST ANOTHER 400ML OF BLOOD IN TRIAGE. ENT TO TAKE PATIENT TO OR FOR POST-TONSILLECTOMY OROPHARYNGEAL BLEEDING. DURING PROCEDURE, ENT FOUND A CLOT ON THE RIGHT SUPERIOR AND MID LATERAL TONSILLAR FOSSA. PATIENT WAS ADMITTED FOR POST-OP OBSERVATION WHERE HE RECEIVED 1 UNIT PRBC TRANSFUSION OVERNIGHT. PATIENT WAS KEPT A 2ND NIGHT DUE TO LOW HGB (9.4). PATIENT CLEARED FOR DISCHARGE TO HOME ON POST OPERATIVE DAY 2. NO OUTCOMES REPORTED AT LAST EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1757004 UNKN COBLATION ENT DEV ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention| O