BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    120MM INSUFF NEEDLE

    MDR report key: 9967242 · Received April 16, 2020

    Report

    Report Number
    1216677-2020-00092
    Event Type
    Malfunction
    Date Received
    April 16, 2020
    Date of Event
    March 3, 2020
    Report Date
    February 7, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    FHO
    UDI-DI
    00888937003666
    PMA / PMN Number
    K970788
    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: INITIATED MANUFACTURER'S INVESTIGATION, NO SAMPLE RETURNED, REVIEW DHR. DISTRIBUTION HISTORY: THE COMPLAINT PRODUCT WAS PURCHASED FROM GEOTEC ON (B)(6) 19. MANUFACTURING RECORD REVIEW: DHR-900-200 - 265897 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW: IQC-19-09-11-032 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 DID NOT SHOW SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT WAS NOT RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT UNIT COULD NOT BE COMPLETED AT THE COMPLAINT UNIT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE UNIT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDING TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT UNIT COULD NOT BE COMPLETED AT THE COMPLAINT UNIT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE UNIT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDING TO THIS INVESTIGATION. ROOT CAUSE: ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTIVE ACTIONS: CORRECTIVE ACTION IS NOT APPLICABLE AT THIS TIME DUE TO THE ABSENCE OF THE AFFECTED SAMPLE FOR INVESTIGATIVE ANALYSIS. NO FURTHER TRAINING REQUIRED AT THIS TIME; COMPLAINT WILL BE MONITORED FOR TRENDING. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    REPORT STATED: "PNEOUMO-MATIC INSUFFLATION NEEDLE SLOW TO OBTAIN/MAINTAIN PNEUMOPERITONEUM. LEAKING NEAR THE WHITE PLASTIC AT THE TOP OF THE DEVICE". 1216677-2020-00092-1 900-200 120MM INSUFF NEEDLE (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. REF E-COMPLAINT-(B)(4) MEDWATCH5093562.

    Description of Event or Problem · 1

    PER MEDWATCH 5093562 REPORT STATED "PNEOUMO-MATIC INSUFFLATION NEEDLE SLOW TO OBTAIN/MAINTAIN PNEUMOPERITONEUM. LEAKING NEAR THE WHITE PLASTIC AT THE TOP OF THE DEVICE". REF E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434250 120MM INSUFF NEEDLE 120MM INSUFF NEEDLE FHO COOPERSURGICAL, INC. 900-200 265897 00888937003666

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other