BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYO FRZ NO GAS

    MDR report key: 15217902 · Received August 12, 2022

    Report

    Report Number
    1216677-2022-00223
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 20, 2022
    Report Date
    August 5, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPER SURGICAL, INC IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION. REVIEW DHR INSPECT RETURNED SAMPLES . *ANALYSIS AND FINDINGS COMPLAINT (B)(4). DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI ON 06/13/2014 UNDER WORK ORDER (B)(4) AND SOLD ON 04/17/2015. MANUFACTURING RECORD REVIEW: DHR-155946 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO SERVICE HISTORY RECORD FOUND FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. HOWEVER, BASED ON LOG (B)(4) THIS UNIT WAS AT CSI ON 07/27/2022. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED NO PHYSICAL DAMAGE. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO THE PULSE SPRING BEING WORN. THIS IS BEING ATTRIBUTED TO NORMAL WEAR AND TEAR ON THE UNIT. FAULT CODE: NO FAULT FAILURE CODE WEAR AND TEAR. *CORRECTION AND/OR CORRECTIVE ACTION THE COMPLAINT UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER. THE PULSE SPRING WAS REPLACED AND THE PULSE ASSEMBLY WAS ADJUSTED. THE UNIT WAS TESTED AND FOUND ACCEPTABLE. *PREVENTATIVE ACTION ACTIVITY. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION.

    Description of Event or Problem · 0

    DEFROST FUNCTION IS NOT WORKING. FS LOG# (B)(4). LL100 CRYO FRZ NO GAS 900019 E-COMPLAINT- (B)(4).

    Description of Event or Problem · 0

    DEFROST FUNCTION IS NOT WORKING. FS LOG# (B)(4). 1216677-2022-00223 LL100 CRYO FRZ NO GAS 900019 E-COMPLAINT(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994854 LL100 CRYO FRZ NO GAS LL100 CRYO FRZ NO GAS GEH COOPERSURGICAL, INC. 900019 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other