BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 KHZ STD TIP/FLUE PK

    MDR report key: 5878686 · Received August 16, 2016

    Report

    Report Number
    3006697299-2016-00170
    Event Type
    Malfunction
    Date Received
    August 16, 2016
    Report Date
    July 27, 2016
    Manufacturer
    INTEGRA LIFESCIENCES(IRELAND)
    Product Code
    LFL
    PMA / PMN Number
    K141674
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 02 SEP 2016. THE PRODUCT WAS NOT RETURNED FOR EVALUATION THUS FAILURE ANALYSIS WAS NOT POSSIBLE SINCE COMPLAINT UNITS HAVE NOT BEEN RECEIVED FOR EVALUATION AND NO PICTURES WERE PROVIDED BY THE REPORTING FACILITY. ACCORDING TO THE DHR REVIEW OF FG LOT 1160294, NO ANOMALIES WERE REPORTED DURING THE ASSEMBLY, CLEANING, PACKAGING AND INSPECTION PROCESSES OF THIS LOT THAT COULD BE RELATED TO THE REPORTED CONDITION ¿FOREIGN BODIES¿. NO PATIENT HARM WAS REPORTED AS PART OF THIS INCIDENT. NO SIMILAR COMPLAINTS RELATED TO ¿FOREIGN BODIES¿ HAVE BEEN REPORTED FOR THE FG LOT 1161327 AND FG LOT 1160294. AFTER REVIEWING THE COMPLAINT SYSTEM FROM 08/03/14 TO 08/03/16, FIVE (5) COMPLAINTS RELATED TO ¿FOREIGN BODIES¿ (INCLUDING THIS COMPLAINT) HAVE BEEN REPORTED. FOR CUSA TIPS AND FLUES, APPROXIMATELY (B)(4) UNITS HAVE BEEN RELEASED FOR DISTRIBUTION FROM 08/03/14 TO 08/03/16, RESULTING IN A COMPLAINT OCCURRENCE RATE OF APPROXIMATELY (B)(4). THIS WAS DETERMINED BY DIVIDING THE NUMBER OF COMPLAINTS¿ UNITS IN THIS CATEGORY (5) BY THE NUMBER OF RELEASED UNITS FOR DISTRIBUTION. CONCLUSION: THE FAILURE ANALYSIS OF COMPLAINT UNITS IS REQUIRED TO DETERMINE THE DEFINITE ROOT CAUSE OF THE REPORTED CONDITION. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED CONDITION AT THIS TIME.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS (SAME PATIENT, SAME SURGERY, DIFFERENT PRODUCT ID, SAME PRODUCT PROBLEM). LINKED TO MFG REPORT: 3006697299-2016-00171. THE C4601 23KHZ HANDPIECE SEEMED BLOCKED UPON BEGINNING OF THE CUSA APPLICATION. THE DEVICE WAS BEING USED ON A (B)(6) YEAR OLD FEMALE PATIENT UNDERGOING A RIGHT HEMICOLECTOMY WITH LIVER RESECTION. A PHONE CALL WAS MADE TO INTEGRA SUPPORT STAFF. ONCE ADVISED, A STYLET WAS PUSHED THROUGH TIP. IT APPEARED THAT 2 FOREIGN BODIES WERE PUSHED OUT OF THE NOSE CONE OPENING AS THE BEVEL OF THE MANIFOLD TUBING WAS TAKEN OUT. THESE PIECES WERE DESCRIBED AS CYLINDRICAL, WHITE AND POSSIBLY PLASTIC LOOKING. THE PATIENT WAS PREPPED FOR SURGERY AND THE SURGERY WAS DELAYED AN ESTIMATED 15-20 MINUTES WHILE THE PHONE SUPPORT WAS SOUGHT. THERE WAS NO REPORT OF PATIENT HARM OR INJURY OR ADVERSE CONSEQUENCE DUE TO THE DELAY. THE PROCEDURE WAS COMPLETED AS EXPECTED AND THE PATIENT'S OUTCOME WAS AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532311 23 KHZ STD TIP/FLUE PK ULTRASONIC SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES(IRELAND) 1161327

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR