BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CFF03, 5X100 KII FIOS ADVFIX 6/BX

    MDR report key: 5112404 · Received September 29, 2015

    Report

    Report Number
    2027111-2015-00681
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 29, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    PMA / PMN Number
    K083638
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FULL UDI# PROVIDED FOR CFF03. ON (B)(6) 2015 AN EPIX UNIVERSAL CLIP APPLIER CA500 USED IN THE PROCEDURE WAS ALSO RETURNED FOR EVALUATION. CATALOG# 101281901 LOT 1247833. FULL UDI# (B)(4). FDA CODE (B)(4), 510K K011236. DATE OF MFR 06/04/2015. DATE OF EXP. 06/03/2018. INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION OF THE UNIT, ENGINEERING FOUND DEBRIS LOCATED AT THE DISTAL END OF THE CLIP APPLIER. ENGINEERING WAS ABLE TO REPLICATE THE CUSTOMER'S EXPERIENCE OF DAMAGE TO THE KII 5MM TROCAR DURING INSERTION OF THE CLIP APPLIER. THE CLIP APPLIER WAS DISASSEMBLED AND ENGINEERING FOUND DAMAGE TO THE SHAFT OF THE DEVICE. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE IS LIKELY THE DAMAGE TO THE CLIP APPLIER SHAFT OF THE DEVICE. DUE TO THE DESIGN OF THE CLIP APPLIER, THE DEVICE MUST FIT DOWN A KII 5MM TROCAR WITH NO INTERFERENCE. ANY INTERFERENCE BETWEEN THE CLIP APPLIER AND TROCAR MAY LEAD TO DAMAGE TO THE TROCAR. NOTE: THE EVENT PROBLEM AND THE RESULTS/CONCLUSIONS OF EVALUATION CODES REFERRED THE CLIP APPLIER. NO WRONG FINDING ON THE TROCAR.

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP CHOLE - "AFTER PASSING CLIP APPLIER THROUGH TROCAR FOR 1ST TIME IT WAS NOTED THAT THERE WAS A CLEAR PLASTIC OR SILICONE MATERIAL SHAVING WRAPPED AROUND WORKING END OF APPLIER THAT APPEARS TO HAVE COME FROM THE TROCAR. ON SUBSEQUENT PASSES THE SAME THING OCCURRED. ALL SHAVINGS WERE REMOVED FROM PATIENT." PATIENT STATUS - OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642610 CFF03, 5X100 KII FIOS ADVFIX 6/BX GCJ GCJ APPLIED MEDICAL CFF03 1248614

    Patients

    Seq Age Sex Outcome Treatment
    1