BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 SHORT SHAFT N20 FRZ

    MDR report key: 11627735 · Received April 7, 2021

    Report

    Report Number
    1216677-2021-00039
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    November 23, 2020
    Report Date
    March 13, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    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

    INVESTIGATION: X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI IN 1984. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE 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 TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT 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. HOWEVER, BASED ON LOG 95355, THIS UNIT WAS AT CSI ON 12/08/2020. 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 ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO WEAR AND TEAR. CORRECTION AND/OR CORRECTIVE ACTION: THE UNIT IS OBSOLETE AND NOT REPAIRABLE. AS NO RESPONSE FROM THE CUSTOMER WAS RECEIVED THE UNIT WAS RETURNED 'AS-IS'. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION. INSPECT RETURNED SAMPLES: ANALYSIS AND FINDINGS: COMPLAINT (B)(4). DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED AT CSI IN 1984. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE 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 TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT 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 ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO WEAR AND TEAR. CORRECTION AND/OR CORRECTIVE ACTION: THE UNIT IS OBSOLETE AND NOT REPAIRABLE. AS NO RESPONSE FROM THE CUSTOMER WAS RECEIVED THE UNIT WAS RETURNED 'AS-IS'. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    CUSTOMER STATED "ABLE TO FREEZE, DEFROST/RELEASE NOT WORKING." REPAIR TECH STATED "OLD STYLE SHORT SHAFT LL100 IS - OBSOLETE AND OLD VERSION TIPS NOT REPAIRABLE." REFERENCE REPAIR ORDER # (B)(4). 1216677-2021-00039 LL100 SHORT SHAFT N20 FRZ 900020 (B)(4).

    Description of Event or Problem · 0

    DEFROST NOT WORKING. LL100 SHORT SHAFT N20 FRZ 900020 (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Description of Event or Problem · 1

    CUSTOMER STATED "ABLE TO FREEZE, DEFROST/RELEASE NOT WORKING". REPAIR TECH STATED "OLD STYLE SHORT SHAFT LL100 IS - OBSOLETE AND OLD VERSION TIPS NOT REPAIRABLE". REFERENCE REPAIR ORDER # (B)(4). LL100 SHORT SHAFT N20 FRZ 900020. E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529262 LL100 SHORT SHAFT N20 FRZ LL100 SHORT SHAFT N20 FRZ GEH COOPERSURGICAL, INC. 900020 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other