BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN.

    MDR report key: 8663336 · Received June 3, 2019

    Report

    Report Number
    1216677-2019-00162
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 28, 2019
    Report Date
    December 15, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483 DISC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF: (B)(4). INVESTIGATION: X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: A REVIEW OF THE 2 YR COMPLAINT HISTORY REVEALS SIMILAR ISSUES. THIS UNIT WAS MANUFACTURED IN 2014 UNDER WO #156643. A REVIEW OF THE DHR REVEALS NO ANOMALIES. SERVICE & REPAIR DID NOT CONFIRM THE COMPLAINT CONDITION. THE UNIT FUNCTIONED TO SPECIFICATIONS. A ROOT CAUSE FOR THIS COMPLAINT CONDITION IS NOT READILY AVAILABLE. A POTENTIAL ROOT CAUSE IS LIKELY DUE TO END USER ERROR. THIS UNIT WAS ALSO NOTED TO HAVE THE ORIGINAL DIAPHRAGM AND UPDATED ACCORDINGLY. PREVIOUS ISSUES WITH THE DIAPHRAGM REQUIRES ALL UNITS NOTED TO HAVE AN ORIGINAL DIAPHRAGM WILL BE UPDATED WHETHER THEY ARE FAULTY OR NOT. THE ISSUE WAS DUE TO A LATEX MATERIAL DEGRADING OVER TIME. A NEW MATERIAL, SILICONE, WAS SELECTED TO REPLACE IT AS IT IS NOT PRONE TO LOSING ITS SEALING FUNCTION AS DID THE LATEX VERSION. A SEAL IS NEEDED FOR THE PNEUMATIC SWITCH TO TURN ON THE POWER. CORRECTION AND/OR CORRECTIVE ACTION: COOPERSURGICAL SERVICE AND REPAIR TEAM REPLACED THE DIAPHRAGM ON THE UNIT AND RETURNED IT TO THE CUSTOMER. SUSTAINING ENGINEERING HAS SUCCESSFULLY TESTED A REPLACEMENT MATERIAL MADE OF SILICONE FOR USE IN REPAIRS GOING FORWARD, ENG-TEST-10341-R. THE IFU WAS ALSO UPDATED TO ADD A SAFETY CHECK VIA ECN-20444. A SERVICE BULLETIN WAS ISSUED TO EXISTING CUSTOMERS INFORMING THEM TO CHECK FOR THIS ISSUE AND RETURN THE UNIT IF NEEDED. ALL PRODUCT IN FG AND SK, AS APPLICABLE, WERE REWORKED TO REPLACE THE PREVIOUS VERSIONS OF THE DFUS ON ALL APPLICABLE PRODUCTS. THE REPAIRED UNIT WILL HAVE BEEN REPAIRED WITH THIS NEW SILICONE MATERIAL. NO APPLICABLE TRAINING TO TRAIN TO. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    CUSTOMER STATED "FOOT PEDAL NOT WORKING (PER CUSTOMER). WHEN TESTED, PROBE DID NOT DO ANYTHING. REFERENCE REPAIR ORDER: 92049. REF: (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED "FOOT PEDAL NOT WORKING (PER CUSTOMER). WHEN TESTED, PROBE DID NOT DO ANYTHING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457089 LEEP SYSTEM 1000 ESU GEN. LEEP SYSTEM 1000 ESU GEN. HGI COOPERSURGICAL, INC. 52969 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other