BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAKC014-07 EXTREMITY TRAY

    MDR report key: 11886394 · Received May 26, 2021

    Report

    Report Number
    1047429-2021-00002
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    May 6, 2021
    Report Date
    June 25, 2021
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    GEI
    UDI-DI
    10809160313060
    PMA / PMN Number
    K143145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED THAT DURING A TOTAL HIP PROCEDURE, THE E-SEP PENCIL CAUGHT FIRE. IT WAS ALSO REPORTED THAT THE SURGEON RECEIVED A BURN ON THE RIGHT FORE-FINGER THAT DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE REPORTED EVENT WAS NOT CONFIRMED. THE SUSPECTED DEVICE WAS NOT AVAILABLE FOR EVALUATION. WITHOUT HAVING THE SUSPECT DEVICE, THE MANUFACTURER IS UNABLE TO DETERMINE WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INCIDENT WAS ALSO INVESTIGATED AT AVID, WHO DOES THE KITING OF THIS COMPONENT INTO THERE KITS AND THERE WERE NO ANOMALIES FOUND AS THE KITING PROCESS WHERE IT FOLLOWED NORMAL PROCEDURES AND INSPECTIONS. ALL INFORMATION REASONABLY KNOWN AS OF 07JUL2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO O&M HALYARD, INC. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVID MEDICAL COMPLAINT DATABASE AS COMPLAINT (B)(4) AND THE O&M HALYARD ADVERSE EVENT ASSESSMENT PROCESS AS RECORD CH-DT-2021-A1-25. THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 24 MAY 2021 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO O&M HALYARD, INC. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVID MEDICAL COMPLAINT DATABASE AS COMPLAINT (B)(4) AND THE O&M HALYARD ADVERSE EVENT ASSESSMENT PROCESS AS RECORD (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ITEM # (B)(4) PENCIL SMOKE EVAC PUSH BUTTON CAUGHT FIRE, EXPLODED AND BURNED THE SURGEON. NO PATIENT INJURY WAS REPORTED. THE SURGEON¿S HAND WAS BURNED. AS OF 05/11/2021, STILL NO WORD FROM HOSPITAL ON STATEMENT FOR EXACT TREATMENT THAT WAS PERFORMED FOLLOWING THE SURGEON¿S HAND GETTING BURNED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787606 LAKC014-07 EXTREMITY TRAY 5312752 PENCIL SMOKE EVAC PUSHBUTTON GEI O&M HALYARD, INC. 5312752 1419188 10809160313060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other