BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN

    MDR report key: 12501851 · Received September 20, 2021

    Report

    Report Number
    1216677-2021-00202
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    August 23, 2021
    Report Date
    November 9, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT 2021-09-0000151 DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 11/07/2013 UNDER WO #155283 AND SHIPPED ON 11/08/2013. MANUFACTURING RECORD REVIEW: DHR 155283 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS SERVICED IN 2018 FOR A DAMAGED DISPLAY. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED NO SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 96897 THIS UNIT WAS AT CSI ON 08/26/2021. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE: THE DISPLAY WAS CONFORMED TO HAVE BEEN DAMAGED. ROOT CAUSE IS BEING ATTRIBUTED TO END USER ERROR. ALTHOUGH NOT PART OF THE COMPLAINT ROOT CAUSE FOR FAILURE 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 THE UNIT'S DISPLAY WAS REPAIRED AND ITS DIAPHRAGM WAS UPDATED. 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 . 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. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    DISPLAY OVERLAY. ORDER: 96897 -COMPLAINT VERIFIED----REPLACED DIAPHGRAM AND OVERLAY. 1216677-2021-00202 LEEP SYSTEM 1000 ESU GEN 52969 E-COMPLAINT-2021-09-0000151.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    DISPLAY OVERLAY. ORDER: (B)(4). COMPLAINT VERIFIED----REPLACED DIAPHGRAM AND OVERLAY. LEEP SYSTEM 1000 ESU GEN 52969. E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400502 LEEP SYSTEM 1000 ESU GEN LEEP SYSTEM 1000 ESU GEN HGI COOPERSURGICAL, INC. 52969 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other