BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARV043-05 PLASTICS BREAST TRAY

    MDR report key: 11980169 · Received June 10, 2021

    Report

    Report Number
    1047429-2021-00004
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    June 1, 2021
    Report Date
    August 3, 2021
    Manufacturer
    O&M HALYARD, INC.
    Product Code
    GEI
    UDI-DI
    10809160205099
    PMA / PMN Number
    K103375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVALUATION. A CUSTOMER COMPLAINT WAS RECEIVED ON THE CAUTERY W/SMOKE TUBING, ITEM NUMBER 5311356. A SUPPLIER CORRECTIVE ACTION REQUEST) WAS SUBMITTED TO COVIDIEN WHO ASSEMBLES THIS COMPONENT. THE ROOT CAUSE OF THE FAILURE WAS NOT IDENTIFIED. ACCORDING TO COVIDIEN , THERE HAS BEEN NO CHANGE TO THE SPECIFICATIONS OR THE SUPPLIER. THEIR INVESTIGATION ALSO REVEALED THAT THERE HAS NOT BEEN A REPORTED OCCURRENCE FOR THE SAME ISSUE DURING THE PAST 5 YEARS. WITHOUT ADDITIONAL INFORMATION ON THE ACTUAL USE AND ADDITIONAL MANUFACTURING STEPS; I.E. PLACEMENT OF THE SPONGE WITH RING AND THE FORCES THE RING ENDURED DURING THE KITTING AND PACKAGING PROCESS, THEY ARE UNABLE TO DETERMINE A ROOT CAUSE. THE INCIDENT WAS ALSO INVESTIGATED AT AVID, WHO DOES THE KITTING OF THIS COMPONENT INTO THEIR KITS AND THERE WERE NO ANOMALIES FOUND IN THE KITTING PROCESS AS IT FOLLOWED NORMAL PROCEDURES AND INSPECTIONS. ALL INFORMATION REASONABLY KNOWN AS OF 26AUG2021 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-A1-33.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT 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 10JUNE2021 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). DEVICE NOT RETURNED

    Description of Event or Problem · 0

    AVID MEDICAL REPORTED COMPLAINT # (B)(4) THAT A CAUTERY PIECE BROKE OFF AND FELL ONTO THE SURGERY WOUND. TWO EVENTS/BOTH HAD THE SAME MANUFACTURING LOT NUMBER/ SAME AVID KIT LOT NUMBER. WHILE USING THE CAUTERY IN THE STANDARD MANNER, THE CLEAR SUCTION PIECE FELL OFF IN THE FIELD AND APPEARS TO HAVE CRACKED. PER DR. (B)(6) STATED, THE BROKEN PIECE OF EACH BOVIE PEN FELL INTO THE SURGICAL WOUND (ONE CASE WAS A BREAST REDUCTION AND THE OTHER CASE WAS A BREAST RECONSTRUCTION CASE. NEITHER THE PATIENT NOR PERSONNEL WERE HARMED. NO PATIENT INJURY WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874627 VARV043-05 PLASTICS BREAST TRAY CAUTERY W/SMOKE TUBING GEI O&M HALYARD, INC. 5311356 1418119 10809160205099

    Patients

    Seq Age Sex Outcome Treatment
    1