BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN.

    MDR report key: 5614262 · Received April 28, 2016

    Report

    Report Number
    1216677-2016-00027
    Event Type
    Malfunction
    Date Received
    April 28, 2016
    Date of Event
    March 4, 2016
    Report Date
    November 9, 2016
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 WAS RETURNED BY THE CUSTOMER AND EVALUATED. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    REF 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 #1676 - 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 REPAIR ORDER LOG (B)(4). PER REPAIR AUTHORIZATION FORM: "CUT OUT DURING PROCEDURE. " (B)(4).

    Description of Event or Problem · 1

    REVIEW OF REPAIR ORDER LOG (B)(4). PER REPAIR AUTHORIZATION FORM: "CUT OUT DURING PROCEDURE." REFERENCE E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273614 LEEP SYSTEM 1000 ESU GEN. LEEP SYSTEM 1000 ESU GEN. HGI COOPERSURGICAL, INC. 52969 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other