BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN.

    MDR report key: 13659483 · Received March 3, 2022

    Report

    Report Number
    1216677-2022-00040
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    January 28, 2022
    Report Date
    April 4, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483 - DC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENLTY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INSPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT 2022-02-0000021 DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 05/07/2009 UNDER WO #70539 AND SHIPPED ON 06/05/2009. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITION. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE FOOT PEDAL HAS BEEN KNOWN TO FAIL DUE TO A FEW REASONS. THE MOST COMMON IS THE DIAPHRAGM IN THE SWITCH (WITHIN THE CONSOLE) WHICH ACTS AS THE MECHANISM TO MAKE AN ELECTRICAL CONTACT TO SUPPLY POWER TO THE UNIT. AIR DISPLACEMENT, GENERATED BY THE FOOT PEDAL, PUSHES ON A PISTON VIA THE DIAPHRAGM IN THE SWITCH TO TURN THE POWER ON. GIVEN THE APPEARANCE OF A BAD DIAPHRAGM IT APPEARS TO HAVE BEEN EXPOSED TO EXCESSIVE STIMULI. LATEX IS FLEXIBLE HENCE THE USE IN THIS APPLICATION BUT ITS ELASTIC PROPERTIES CAN ALTER OVER TIME AS WELL. IN THIS CONDITION, THE SEALING PROPERTIES ARE IMPACTED. THE ROOT CAUSE FOR THIS COMPLAINT CONDITION IS COMPONENT RELATED TO THE DIAPHRAGM. CORRECTIVE ACTIONS COOPERSURGICAL SERVICE AND REPAIR REPLACED THE DIAPHRAGM ON THE UNIT, TESTED IT AND RETURNED IT TO THE CUSTOMER. 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 TRAINING IS REQUIRED. *WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    EVAL. REPLACED DIAPHRAGM. REPAIR ORDER 97765. LEEP SYSTEM 1000 ESU GEN 52969 E-COMPLAINT(B)(4).

    Description of Event or Problem · 0

    EVAL. REPLACED DIAPHRAGM. REPAIR ORDER (B)(4). 1216677-2022-00040-1 LEEP SYSTEM 1000 ESU GEN 52969 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2690717 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