BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU.GEN.

    MDR report key: 5614237 · Received April 28, 2016

    Report

    Report Number
    1216677-2016-00013
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    January 7, 2016
    Report Date
    November 9, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT HAS BEEN RETURNED BY THE CUSTOMER AND EVALUATED. ONCE THE INVESTIGATION PROCESS IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    REFERENCE E-COMPLAINT (B)(4). PLEASE FIND ATTACHED THE LEEP 1000 FINAL MDR SUBMISSION PACKAGE, REGARDING ALL INITIAL MDR'S, AND RETRO REVIEW INITIAL MDR'S FILED FOR REPORTS OF INTERMITTENT FUNCTION DURING USE. THE DOCUMENTS INCLUDED IN THIS PACKAGE ARE AS FOLLOWS: · LEEP SYSTEM INVESTIGATION SUMMARY · LEEP 1000 TECH BULLETIN COVER LETTER · TECH SERVICE BULLETIN 12151 · PROJECT #(B)(4)- LEEP SYSTEM 1000 ROOT CAUSE. THIS CONCLUDES COOPERSURGICAL' S ROOT CAUSE INVESTIGATION. COOPERSURGICAL, INC. WILL CONTINUE TO MONITOR THE COMPLAINT CONDITION FOR TENDING AND SAFETY.

    Description of Event or Problem · 1

    REVIEW OF SERVICE AND REPAIR LOGS REFERENCE REPAIR ORDER LOG (B)(4). PER REPAIR AUTHORIZATION FORM: "INTERMITTENT HEAT PROBLEM WHEN CUTTING." "NOT HOT AT TIMES DURING THE PROCEDURE." (B)(4).

    Description of Event or Problem · 1

    REVIEW OF SERVICE AND REPAIR LOGS REFERENCE REPAIR ORDER LOG (B)(4)- PER REPAIR AUTHORIZATION FORM "INTERMITTENT HEAT PROBLEM WHEN CUTTING." "NOT HOT AT TIMES DURING THE PROCEDURE." REF E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273898 LEEP SYSTEM 1000 ESU.GEN. LEEP SYSTEM 1000 HGI COOPERSURGICAL, INC. 52969 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other