BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP SYSTEM 1000 ESU GEN.

    MDR report key: 10401105 · Received August 13, 2020

    Report

    Report Number
    1216677-2020-00175
    Event Type
    Malfunction
    Date Received
    August 13, 2020
    Date of Event
    July 23, 2020
    Report Date
    August 13, 2020
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    PMA / PMN Number
    K952483DISCO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. X- INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI ON 08/05/2010 UNDER WO# (B)(4) AND SHIPPED ON 8/27/2010. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THIS TIME. HOWEVER, AT THE TIME OF MANUFACTURE, RECORDS FROM EACH UNIT ARE REVIEWED TO ENSURE THAT PRODUCT MEET ALL SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED, THIS COMPLAINT WILL BE AMENDED ACCORDINGLY. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG 94659, THIS UNIT WAS AT CSI ON 7/29/2020. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: UNIT WAS NOT FUNCTIONING PROPERLY. ROOT CAUSE: A LOOSE HANDPIECE SOCKET CONNECTION IS DUE TO WEAR AND TEAR. THE DIAPHRAGM WAS CHANGED OUT DUE TO A PREVIOUS FINDING WHERE THE MATERIAL DEGRADED TO THE POINT WHERE IT NO LONGER FUNCTIONED AS INTENDED AND PREVENTS ACTIVATION OF A UNIT. THIS UNIT'S DIAPHRAGM WAS IN WORKING ORDER. HOWEVER, THE CORRECTIVE ACTION FOR THIS ISSUE REQUIRES RETURNED UNITS BE UPDATED TO THE NEW MATERIAL AND APPLICABLE ON THIS UNIT. CORRECTION AND/OR CORRECTIVE ACTION / *PREVENTATIVE ACTION ACTIVITY THE UNIT WAS REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TOT HE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. CORRECTIVE ACTIONS RELEVANT TO THE UPDATED DIAPHRAGM ARE AS FOLLOWS; 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 FURTHER TRAINING REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    LOOSE CONN. ON PROBE. S&R HAD TO REPLACE DIAPHGRAM. ORDER: (B)(4). REF: (B)(4). 1216677-2020-00175 LEEP SYSTEM 1000 ESU GEN 52969 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    LOOSE CONN. ON PROBE. S&R HAD TO REPLACE DIAPHGRAM. ORDER: 94659. REF: E-COMPLAINT-(B)(4). LEEP SYSTEM 1000 ESU GEN 52969 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869489 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