BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAPETTE,500 PER BOX,CYTYC

    MDR report key: 10719330 · Received October 22, 2020

    Report

    Report Number
    1216677-2020-00243
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    October 9, 2020
    Report Date
    February 8, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HHT
    UDI-DI
    00888937013290
    PMA / PMN Number
    K896065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION NO SAMPLE RETURNED REVIEW DHR DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS MANUFACTURED AT CSI IN MARCH 2019 UNDER WORK ORDER 254642. MANUFACTURING RECORD REVIEW DHR19MPG002083 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW INCOMING INSPECTION RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. SERVICE HISTORY RECORD SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWS ONE OTHER SIMILAR REPORTED COMPLAINT CONDITION. 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 SEE ATTACHMENT FOR ROOT CAUSE. CORRECTIVE ACTIONS NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    REPORT STATED: " BROOMHEAD FROM THE THINPREP COLLECTION DEVICE COME OFF INSIDE A PATIENT. PATIENT WAS REFERRED TO THE OBGYN GROUP, WOMEN'S CARE SOUTH (TUFTS MEDICAL CENTER) IN BRAINTREE. THEY WERE ABLE TO RETRIEVE THE HEAD, BUT THERE WAS A TEAR TO THE SEPTUM". 1216677-2020-00243-1 908006 PAPETTE 500 PER BOX CYTYC E-COMPLAINT-2020-10-0000173.

    Additional Manufacturer Narrative · 1

    (B)(4), INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    E-COMPLAINT- (B)(4). REPORT STATED"TECHNICAL SUPPORT ENTERED INTO OUR COMPLAINT DATABASE ON FRIDAY DETAILING A INJURY TO A PATIENT BY A PAPETTE MANUFACTURED BY COOPER SURGICAL - BROOMHEAD FROM THE THINPREP COLLECTION DEVICE COME OFF INSIDE A PATIENT. PATIENT WAS REFERRED TO THE OBGYN GROUP, (B)(6). THEY WERE ABLE TO RETRIEVE THE HEAD, BUT THERE WAS A TEAR TO THE SEPTUM. SEVERITY OF THE INJURY AND DETAILS ON HOW IT OCCURRED - HYMENAL SEPTUM 8 TO 9MM THAT TORE AND WILL HEAL ON ITS ON (NURSE PRACTITIONER)/MINIMAL PATIENT DISCOMFORT AND WILL HEAL ON ITS OWN. PAPETTE 500 PER BOX CYTYC 908006 E-COMPLAINT- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188228 PAPETTE,500 PER BOX,CYTYC PAPETTE,500 PER BOX,CYTYC HHT COOPERSURGICAL, INC. 908006 254642 00888937013290

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other