BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN COBLATION DEVICE

    MDR report key: 18608981 · Received January 30, 2024

    Report

    Report Number
    3006524618-2024-00036
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    December 4, 2023
    Report Date
    August 30, 2024
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4). D4, LOT NO.: THE FOLLOWING ARE THE PART NUMBERS & LOT NUMBERS REPORTED: PART NUMBER: EICA5874-01/LOT NUMBER: 2130647 (2 DEVICES), PART NUMBER: EICA5874-01/LOT NUMBER: 2129111 (1 DEVICE), AND PART NUMBER: UNKNOWN SYSTEM 2000 CONTROLLER/LOT NUMBER: UNKNOWN (1 DEVICE), HOWEVER, IT IS UNKNOWN WHICH OF THE 4 DEVICES CONTRIBUTED WITH THE DELAY GREATER THAN 30 MINUTES. D4, EXP. DATE: EXPIRATION DATES FOR EACH OF THE 2 LOT NUMBERS REPORTED: 12-SEP-2026 (2 DEVICES: EICA5874-01/LOT NUMBER: 2130647) & 31-AUG-2026 (1 DEVICE: EICA5874-01/LOT NUMBER: 2129111). H4, MGF. DATE: MANUFACTURING DATES FOR EACH OF THE 2 LOT NUMBERS REPORTED: 12-SEP-2023 (2 DEVICES: EICA5874-01/LOT NUMBER: 2130647) & 31-AUG-2023 (1 DEVICE: EICA5874-01/LOT NUMBER: 2129111). D1: BRAND NAME WAS CHANGED TO UNKNOWN DUE TO THE TWO PART NUMBERS REPORTED: EICA5874-01 & UNKNOWN SYSTEM 2000 CONTROLLER.

    Additional Manufacturer Narrative · 0

    H10: H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE REPORTED DEVICES WERE RECEIVED FOR EVALUATION. THERE IS NO IDENTIFICATION AS TO WHICH DEVICE BELONGS TO WHICH LOT NUMBER. VISUAL INSPECTION OBSERVED THE THREE RETURNED DEVICES SHOW NO MANUFACTURING ABNORMALITIES. FLUID IS IN THE FLUID LINE OF ALL THREE DEVICES. ELECTRODES OF ALL THREE DEVICES HAVE BEEN USED. BIO DEBRIS IS PRESENT ON ALL THREE. THE DEVICES WERE RETURNED TOGETHER IN ONE BAG AND WAS OUT OF THE ORIGINAL PACKAGING. NO PACKAGING RETURNED. TWO DEVICES WERE EACH PLUGGED INTO THE CONTROLLER AND REGISTERED SETTINGS (7,3). THE WANDS WERE ABLE TO GENERATE PLASMA AND COAGULATION. THE THIRD DEVICE WAS PLUGGED INTO THE CONTROLLER AND REGISTERED SETTINGS (0,3). WHEN USED WITH A BYPASS BOX THE WAND WAS ABLE TO GENERATE PLASMA AND COAGULATION AS INTENDED. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE INVESTIGATION. FACTORS THAT CAN CONTRIBUTE TO THE REPORTED EVENT INCLUDE FAILURE OF A CONCOMITANT DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING TONSILLECTOMY AND ADENOIDECTOMY, THREE (3) EVAC 70 COBLATOR WANDS AND ONE (1) FOOT PEDAL WERE NOT WORKING CORRECTLY. THE HANDPIECE WAS REPLACED 3 TIMES, AND THE FOOT PEDAL ONCE. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250224 UNKNOWN COBLATION DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHROCARE CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female