BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN

    MDR report key: 12337795 · Received August 18, 2021

    Report

    Report Number
    1216677-2021-00169
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 28, 2021
    Report Date
    November 8, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NVESTIGATION X-INPECT RETURNED SAMPLES *ANALYSIS AND FINDINGS COMPLAINT 2021-08-0000006 DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 05/16/2003 UNDER WO #23420 AND SHIPPED ON 5/28/2003. 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: THIS UNIT WAS SERVICED IN 2012 FOR A DAMAGED DIAPHRAGM. 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 LOG 96756. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND TO FUNCTION PROPERLY. ROOT CAUSE: THE PRODUCT TESTED TO SPECIFICATION AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. 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 WAS EVALUATED, UPDATED WITH A NEW DIAPHRAGM AND RETURNED TO THE CUSTOMER. PERTAINING TO THE DIAPHRAGM: SUSTAINING ENGINEERING HAS SUCCESSFULLY TESTED A REPLACEMENT MATERIAL MADE OF SILICONE FOR USE IN ASSEMBLY AND REPAIRS GOING FORWARD. THE IFU WAS ALSO UPDATED TO ADD A SAFETY CHECK VIA ECN-20444, P/N 35387B. 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. CORRECTION ACTIVITY IN 2016. *PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. REF: (B)(4).

    Description of Event or Problem · 0

    NO REPAIR FORM, EVAL. ORDER: 96756 REPLACED DIAPHGRAM FUNCTIONS TO SPEC. 1216677-2021-00169 LEEP SYSTEM 1000 ESU GEN 52969 E-COMPLAINT-2021-08-0000006.

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Description of Event or Problem · 1

    NO REPAIR FORM, EVAL. ORDER: 96756. REPLACED DIAPHRAM FUNCTIONS TO SPEC. 1216677-2021-00169 LEEP SYSTEM 1000 ESU GEN 52969. E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236431 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