BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEMO LEEP PRECISION

    MDR report key: 16406105 · Received February 20, 2023

    Report

    Report Number
    1216677-2023-00033
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    February 1, 2023
    Report Date
    May 1, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    4/3/20203 - CORRECTION TO SECTION D1 D2 & D4 AS IT PERTAINS TO PART NUMBER & DECSRIPTION. 2/20/2023 - COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES ANALYSIS AND FINDINGS COMPLAINT (B)(4). WAS THE COMPLAINT CONFIRMED? YES. DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 12/22/201 UNDER WO (B)(4) AND SHIPPED ON 4/11/2015 AND 11/27/2017. MANUFACTURING RECORD REVIEW: DHR'S 258555, 265279 & 203387 WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: THIS UNIT WAS RETURNED ON COMPLAINT FOR A BAD CRIMP IN 2016, REPAIRED AND CONVERTED TO A DEMO. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. THE ISSUE WAS IDENTIFIED AND ADDRESSED. SEE ROOT CAUSE AND CORRECTIVE ACTION SECTIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO OUTER PHYSICAL DAMAGE. HOWEVER, UPON REMOVAL OF THE HOUSING THERE WERE 2 DAMAGED COMPONENTS ON THE DISPLAY BOARD. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: AN INITIAL INVESTIGATION BY TECHNICAL OPERATIONS (CSI'S ENGINEERING DEPT.) HAS INDICATED RESISTORS R9 AND R14 WERE BURNT OUT DUE TO BEING EXPOSED TO CURRENT OUTSIDE THEIR RATING. THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO UNDER RATED RESISTORS. CORRECTION AND/OR CORRECTIVE ACTION / *PREVENTATIVE ACTION ACTIVITY THE UNIT WAS FITTED WITH A NEW BOARD, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. THE RESISTERS WERE UPDATED TO A HIGHER RATING ON THE BOARDS VIA ECN-23707. A REDLINE WAS PROVIDED TO THE BOARD VENDOR TO PRODUCE BOARDS IN THEIR WIP TO INCLUDE THE NEW RESISTORS AND CSI INVENTORY WAS RE-WORKED WO (B)(4) TO HAVE THE RESISTORS REPLACED. NO ADDITIONAL TRAINING REQUIRED.

    Description of Event or Problem · 0

    AS PER DETAILS REPORTED ON E-COMPLAINT (B)(4) FROM REPAIR ORDER LOG # (B)(4). "NO OUTPUT. UNIT SMELLS OF BURNT ELECTRONICS, CONTROLS AND DISPLAY NOT WORKING. NO OUTPUT." THIS "UNIT WAS SALES DEMO PURCHASED 10/22 UNDER WARRANTY PER SALES REP".

    Description of Event or Problem · 0

    AS PER DETAILS REPORTED ON E-COMPLAINT (B)(4) FROM REPAIR ORDER LOG # 99883. "NO OUTPUT. UNIT SMELLS OF BURNT ELECTRONICS, CONTROLS AND DISPLAY NOT WORKING. NO OUTPUT." THIS "UNIT WAS SALES DEMO PURCHASED 10/22 UNDER WARRANTY PER SALES REP."

    Description of Event or Problem · 0

    AS PER DETAILS REPORTED ON E-COMPLAINT (B)(4) FROM REPAIR ORDER LOG (B)(4). "NO OUTPUT. UNIT SMELLS OF BURNT ELECTRONICS, CONTROLS AND DISPLAY NOT WORKING. NO OUTPUT." THIS "UNIT WAS SALES DEMO PURCHASED 10/22 UNDER WARRANTY PER SALES REP"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644082 DEMO LEEP PRECISION DEMO LEEP PRECISION HGI COOPERSURGICAL, INC. DMLP-20-120 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other