BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC HANDPIECE LAPAROSCOPIC

    MDR report key: 8349414 · Received February 19, 2019

    Report

    Report Number
    3007305485-2019-00033
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    December 19, 2018
    Report Date
    March 27, 2019
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    HAM
    PMA / PMN Number
    K925903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    CORRECTION: PREVIOUSLY STATED CATALOG # 130344, LOT # 201810294 CORRECTED TO CATALOG # 160656, NO LOT # PROVIDED. PREVIOUSLY STATED K871435 CORRECTED TO K925903. TWO 160656 WERE RECEIVED, ONE IN OPENED UNORIGINAL PACKAGING THE OTHER IN OPENED ORIGINAL PACKAGING, THE REPORTED CATALOG NUMBER WAS VERIFIED, THE LOT NUMBER WAS NOT VERIFIED. VISUAL INSPECTION FOUND THAT THE DEVICE THAT DID NOT HAVE ORIGINAL PACKAGING APPEARED BURNT AT THE DISTAL END AND THAT THE SHAFT AND COATING WERE DAMAGED. THE DEVICE WAS ALSO FUNCTIONALLY INSPECTED WITH A SYSTEM 7500 ESU ((B)(4)). FUNCTIONAL INSPECTION FOUND THAT THE ARGON BEAM EJECTED STRAIGHT FROM THE TIP AND DID NOT APPEAR TO ARC OR CREEP ALONG THE SIDES. NO SMOKE, FIRE, OR SPARKING WAS OBSERVED DURING TESTING. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED DUE TO NO LOT NUMBER BEING PROVIDED. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; NOT TO USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS, DISINFECTING AGENTS, OXYGEN-RICH ENVIRONMENTS OR OTHER COMBUSTIBLE MATERIALS. BEFORE USE, INSPECT THE CORD INSULATION AND HAND PIECE INTEGRITY AND CONDITION. IF DAMAGED, CHIPPED, CUT, OR NICKED, DO NOT USE THE HAND PIECE /PROBE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    CORRECTION: PREVIOUSLY STATED THE DATE OF INCIDENT WAS (B)(6) 2018, THE DATE OF INCIDENT IS ACTUALLY (B)(6) 2019. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    CORRECTION: PREVIOUSLY STATED THE DATE OF INCIDENT WAS (B)(6) 2019, THE DATE OF INCIDENT IS ACTUALLY (B)(6) 2018. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 130344, SINGLE FUNCTION ABC HANDPIECE, CAUGHT FIRE AT THE TIP DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON "(B)(6)" 2018. THE FIRE WAS IN THE STERILE FIELD AT THE TIME, BUT IT WAS STOMPED OUT BY THE SURGEON. THERE WERE NO PATIENT OR USER INJURIES. THE SURGICAL TEAM WAS FAMILIAR WITH THE PRODUCT DUE TO CONTINUOUS EDUCATION BY NURSING STAFF. THE ABC HANDPIECE WAS STORED IN THE HOLSTER IN THE STERILE FIELD WHEN NOT IN USE. THE HANDPIECE WAS ATTACHED TO THE 7550 ARGON GENERATOR. THE HANDPIECE WAS CHECKED PRIOR TO SURGERY. IT IS UNKNOWN HOW LONG THE HANDPIECE WAS IN USE BEFORE IT CAUGHT FIRE. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143429 ABC HANDPIECE LAPAROSCOPIC ARGON HANDPIECE HAM CONSOLIDATED MEDICAL EQUIPMENT 201810294

    Patients

    Seq Age Sex Outcome Treatment
    1