BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEEP AUVARD SPECULUM LG

    MDR report key: 14887686 · Received July 1, 2022

    Report

    Report Number
    1216677-2021-00199
    Event Type
    Malfunction
    Date Received
    July 1, 2022
    Date of Event
    June 8, 2022
    Report Date
    July 8, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HDF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION . X-NO SAMPLE RETURNED . X-REVIEW DHR. *ANALYSIS AND FINDINGS : DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT (LOT 1911141) WAS PURCHASED FROM REDA THEN SENT FOR COATING BY VITEK, PACKAGED BY CSI ON (B)(6) 2020 UNDER WORK ORDER (B)(4) , AND SOLD ON (B)(6) 2022. MANUFACTURING RECORD REVIEW: (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: IQC RECORD- F232-01 (COATED PART RECEIVED FROM VITEK) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED ONE ADDITIONAL SIMILAR REPORTED COMPLAINT CONDITIONS. THERE IS ONE ADDITIONAL COMPLAINT FROM A DIFFERENT LOT REGARDING CHIPS IN THE COATING. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. *CORRECTION AND/OR CORRECTIVE ACTION NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME. *PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. **PLEASE NOTE THE FOLLOWING CORRECTIONS TO PREVIOUS REPORT - FILE NAME: (B)(4). STATUS: DELIVERED. **MANUFACTURER REPORT NUMBER 1216677-2022-00199. PREVIOUSLY INCORRECTLY SUBMITTED AS 1216677-2021-00199. **B5 REFERENCED SUBMISSION NAME 1216677-2021-00199 LEEP AUVARD SPECULUM LG F232 (B)(4). PREVIOUSLY INCORRECTLY REFERRENCED AS 1216677-2021-00199 LEEP AUVARD SPECULUM LG F232 (B)(4). COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 0

    REPORT STATED COATING IS COMING OFF. LEEP AUVARD SPECULUM LG F232 E-COMPLAINT-(B)(4).

    Description of Event or Problem · 0

    REPORT STATED COATING IS COMING OFF. 1216677-2022-00199 LEEP AUVARD SPECULUM LG F232 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383599 LEEP AUVARD SPECULUM LG LEEP AUVARD SPECULUM LG HDF COOPERSURGICAL, INC. F232 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other