BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIS NSMF INS TI IRR BAY 8.75", 1.5MM

    MDR report key: 7197338 · Received January 16, 2018

    Report

    Report Number
    1226348-2018-10075
    Event Type
    Malfunction
    Date Received
    January 16, 2018
    Date of Event
    December 29, 2017
    Product Code
    GEI
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE STYLET (IRRIGATION BI FCP STYLETS) WAS NOT RETURNED FOR EVALUATION. THE FORCEPS WAS RECEIVED INSIDE THE ORIGINAL PACKAGING. HOWEVER, THE PLASTIC POUCH APPEARS TO HAVE BEEN OPEN. VISUAL EVALUATION OF THE FORCEPS DID NOT REVEAL ANY ANOMALIES, THE DISTAL FLOW PATH APPEARED CLEAN AND OPEN. A CONTROL STYLET COULD BE EASILY INSERTED INTO THE FLOW PATH WITH NO RESISTANCE AND COULD BE ADVANCE THE ENTIRE LENGTH OF THE FLOW PATH INDICATING THAT THE FLOW PATH IS UNOBSTRUCTED. THE REPORTED "STYLET BROKE OFF DURING TESTING/CLEANING" COULD NOT BE CONFIRMED IN THE LABORATORY. THE BROKEN STYLET WAS NO RETURNED FOR EVALUATION, AS SUCH IT IS NOT POSSIBLE TO EVALUATE THE STYLET AND VERIFY THE REPORTED "STYLET BROKE". WE WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR COMPLAINTS FOR THIS PRODUCT CODE. THE LOT NUMBER WAS NOT PROVIDED FOR 801130STYLET, THEREFORE; THE DHR COULD NOT BE REVIEWED. THE MOST RECENT COMPLAINT AND SMT PRESENTATION HAS BEEN REVIEWED AND THIS PRODUCT FAMILY DID NOT EXCEED THE UPPER CONTROL LIMIT FOR COMPLAINTS. THE DHR FOR THE RETURNED FORCEPS P/C 802988 DID NOT REVEAL ANY ANOMALIES DURING THE MANUFACTURING PROCESSES. A REVIEW OF COMPLAINT RECORDS (FOR FORCEPS) FOR THE PREVIOUS 12 MONTHS DID NOT IDENTIFY ANY CONFIRMED SIMILAR COMPLAINTS FOR THIS LOT AND PRODUCT CODE COMBINATION. NO FURTHER ACTION IS REQUIRED. THIS COMPLAINT IS CONSIDERED TO BE CLOSED, SHOULD THE STYLET BE RETURNED AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED AND AN INVESTIGATION WILL BE PERFORMED. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AS REPORTED BY THE US REP, A NEW CODMAN FORCEP STYLET BROKE OFF DURING TESTING / CLEANING. EVENT DID NOT OCCUR INTRA OPERATIVELY; NO DELAYS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39095 MALIS NSMF INS TI IRR BAY 8.75", 1.5MM DEVICE, ELECTROSURGICAL, CUTTING & COAG & ACC. GEI 1702

    Patients

    Seq Age Sex Outcome Treatment
    1