BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM

    MDR report key: 5736723 · Received June 20, 2016

    Report

    Report Number
    1216677-2016-00045
    Event Type
    Malfunction
    Date Received
    June 20, 2016
    Date of Event
    May 6, 2016
    Report Date
    November 10, 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 HAS NOT YET BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. 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 #(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

    SUMMARY SURGERY/PROCEDURE EVENT (B)(6). INCIDENT DESCRIPTION: LEEP PROCEDURE, GROUNDING PAD LOCATED ON UPPER LEFT THIGH, PLUGGED INTO MACHINE, WHEN THE PHYSICIAN WAS USING CUTTING FEATURE AT 46W POWER THERE WERE NO ISSUES, AND THEN UNIT WAS SWITCHED OVER TO CAUTERY TOOL, UNIT POWER WAS SET AT 36W, HALFWAY THROUGH THE PROCEDURE WHEN USING BALL TO CAUTERIZE, PATIENT JUMPED AND CLAIMED OF PAIN, INSULATED SPECULUM IN PLACE, DR WITHDREW CAUTERIZE TOOL AND OBSERVED 2 BURNED SPOTS ON SIDES OF PROCEDURE AREA. PROCEDURE WAS IMMEDIATELY HALTED AND DIFFERENT METHODS WERE USED TO TREAT PATIENT NATURE OF INJURY - BURN. LOCATION OF INJURY ON BODY - VAGINA. HARM - TEMPORARY, INTERVENTION NEEDED. (B)(4).

    Description of Event or Problem · 1

    SUMMARYSURGERY/PROCEDURE EVENT (B)(4). INCIDENT DESCRIPTION: LEEP PROCEDURE, GROUNDING PAD LOCATED ON UPPER LEFT THIGH, PLUGGED INTO MACHINE, WHEN THE PHYSICIAN WAS USING CUTTING FEATURE AT 46W POWER THERE WERE NO ISSUES, AND THEN UNIT WAS SWITCHED OVER TO CAUTERY TOOL, UNIT POWER WAS SET AT 36W, HALFWAY THROUGH THE PROCEDURE WHEN USING BALL TO CAUTERIZE, PATIENT JUMPED AND CLAIMED OF PAIN, INSULATED SPECULUM IN PLACE, DR WITHDREW CAUTERIZE TOOL AND OBSERVED 2 BURNED SPOTS ON SIDES OF PROCEDURE AREA. PROCEDURE WAS IMMEDIATELY HALTED AND DIFFERENT METHODS WERE USED TO TREAT PATIENT. NATURE OF INJURY - BURN, LOCATION OF INJURY ON BODY - VAGINA, HARM - TEMPORARY, INTERVENTION NEEDED. REFERENCE E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391859 LEEP SYSTEM LEEP SYSTEM HGI COOPERSURGICAL, INC. 52969 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R