BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA090, DIRECT DRIVE LCA 3/BX

    MDR report key: 5167126 · Received October 21, 2015

    Report

    Report Number
    2027111-2015-00736
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 29, 2015
    Manufacturer
    APPLIED MEDICAL
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE INCIDENT PRODUCT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOTS CONFIRMED THAT THE PRODUCT PASSED ALL MANUFACTURING AND QUALITY INSPECTIONS. ALL CLIP APPLIERS UNDERGO 100% VISUAL AND FUNCTIONAL INSPECTION DURING THE MANUFACTURING AND ASSEMBLY PROCESS. AS A PART OF THIS PROCESS, EACH UNIT IS INSPECTED FOR CLIP FEEDING DURING MANUFACTURING PRIOR TO PACKAGING. ALTHOUGH THE ROOT CAUSE OF YOUR EXPERIENCE COULD NOT BE DETERMINED, APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. THIS DOCUMENT REPRESENTS OUR INITIAL / FINAL REPORT.

    Description of Event or Problem · 1

    LAPAROSCOPIC CHOLECYSTECTOMY- "THIS IS A COMPLAINT FROM THE MARKET. (B)(4). THE EVENT UNIT WILL NOT BE RETURNED TO AMR AS IT WAS DISPOSED OF BY THE FACILITY. PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION. REQUEST:OLYMPUS COULD NOT IDENTIFY THE LOT NUMBER OF THE EVENT UNIT. PLEASE REVIEW THE DHR OF THE FOLLOWING LOTS. NO CREDIT OR REPLACEMENT IS NEEDED. POSSIBLE LOTS OF THE EVENT UNIT: 1207320, 1203291, 1203554, 1205682, 1213133." COMPLAINT SHEET- "THIS IS AN INCIDENT OCCURRED AFTER A LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED ON (B)(6) 2015. A CLIP CLIPPING THE CYSTIC DUCT CAME OFF AND BILE LEAKED TO THE ABDOMINAL CAVITY. REOPERATION WAS PERFORMED ON THE PATIENT TO IRRIGATE THE ABDOMINAL CAVITY ON (B)(6) 2015 AND THE CLIP WAS SUCCESSFULLY RETRIEVED. THE CONDITION OF THE PATIENT IS STABLE. BEFORE THE CHOLECYSTECTOMY, ONE OF THE CLIPS WAS NOT PROPERLY FED AND FELL OUTSIDE THE BODY. AS THE OTHER CLIPS WERE FED PROPERLY, THE PHYSICIAN USED THE EVENT UNIT FOR THE PROCEDURE. THE PHYSICIAN WONDERS IF THERE IS A RELATION BETWEEN THIS FEEDING FAILURE AND THE INCIDENT. THE EVENT UNIT WAS DISPOSED OF BY THE USER FACILITY AND WILL NOT BE RETURNED TO AMR. (B)(4). REQUEST: OLYMPUS COULD NOT IDENTIFY THE LOT NUMBER OF THE EVENT UNIT. PLEASE REVIEW THE DHR OF THE FOLLOWING LOTS. NO CREDIT OR REPLACEMENT IS NEEDED. POSSIBLE LOTS OF THE EVENT UNIT: 1207320, 1203291, 1203554, 1205682, 1213133." PATIENT STATUS - "OK "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697588 CA090, DIRECT DRIVE LCA 3/BX FZP FZP APPLIED MEDICAL CA090 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R