BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRONNER MANIPUJECTOR BOX

    MDR report key: 5612425 · Received April 27, 2016

    Report

    Report Number
    1216677-2015-00053
    Event Type
    Malfunction
    Date Received
    April 27, 2016
    Date of Event
    August 3, 2015
    Report Date
    October 15, 2015
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ON 08/06/2015 COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED BY THE CUSTOMER FOR EVALUATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE FILED. (B)(4). ON 10/22/2015 INVESTIGATION SUMMARY REPORT: INITIATED MANUFACTURER'S INVESTIGATION. NO SAMPLE RETURNED. REVIEW DHR. THE REPORTED COMPLAINT EVENT CANNOT BE CONFIRMED OR VERIFIED AS THE AFFECTED SAMPLE WILL NOT BE RETURNED FOR ANALYSIS. THE KRONER PRODUCT LINE IS PACKAGED AT COOPER SURGICAL, (B)(4) AND THE ASSEMBLY ITSELF IS MANUFACTURED BY AN OUTSIDE VENDOR FOR COOPER SURGICAL. THE MANUFACTURER OF THE KRONNER DEVICE (B)(4) HAS BEEN CONTACTED FOR THE REVIEW INVESTIGATION OF VENDOR PART NUMBER 52867; LOT NUMBER M12650 THAT WAS USED IN WORK ORDER (B)(4). ACCORDING TO (B)(4) VIA RETURNED CORRESPONDENCE, ALL KRONER PRODUCT IS SUBJECTED TO 100% INFLATION TESTING AS PART OF THE ACCEPTANCE CRITERIA, A REVIEW OF THEIR RECORDS DID NOT INDICATE ANY ANOMALY AND NOTHING HAS CHANGED IN THE MANUFACTURING PROCESS. REVIEW OF COOPER SURGICAL INCOMING INSPECTION RECORDS NOTED THAT VENDOR LOT M12650, PART NUMBER 52867 WAS SAMPLED AND RECEIPT WAS ACCEPTED FOR INFLATION AND LEAK TESTING. BASED ON ALL THE DOCUMENTATION ASSOCIATED TO WORK ORDER (B)(4) AND THE ABSENCE OF THE AFFECTED SAMPLE AS OBJECTIVE EVIDENCE A ROOT CAUSE IS INDETERMINABLE. REVIEW OF PAST SIMILAR COMPLAINTS FOR THIS PRODUCT FAMILY DETERMINED THAT THE MOST LIKELY CAUSE WAS ATTRIBUTED TO IMPROPER USE OR MISHANDLING OF THE DEVICE CONTRARY TO THE DFU INSTRUCTIONS FOR USE. REVIEW OF THE DHR FOR WORK ORDER (B)(4) DID NOT REVEAL ANY ABNORMALITIES, SEE ATTACHED. PER BSR-QAR-026 THIS COMPLAINT WILL BE MONITORED FOR TRENDING IN THAT NO INJURY WAS REPORTED TO END USER, OR PATIENT.

    Description of Event or Problem · 1

    "WHEN DOCTOR REMOVED DEVICE, HE NOTICED THE BALLOON AND TIP HAD BROKEN OFF. DOCTOR REMOVED DEBRIS FROM THE INNER CERVICAL OS." (B)(4).

    Description of Event or Problem · 1

    "WHEN DOCTOR REMOVED DEVICE, HE NOTICED THE BALLOON AND TIP HAD BROKEN OFF. DOCTOR REMOVED DEBRIS FROM THE INNER CERVICAL OS." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269141 KRONNER MANIPUJECTOR BOX KRONNER MANIPUJECTOR BOX LKF COOPERSURGICAL, INC. 6003 179927

    Patients

    Seq Age Sex Outcome Treatment
    1 Other