BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRONNER MANIPUJECTOR

    MDR report key: 7496081 · Received May 8, 2018

    Report

    Report Number
    1216677-2018-00023
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 10, 2018
    Report Date
    October 26, 2018
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HES
    PMA / PMN Number
    K904473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: X-INITIATED MANUFACTURER'S INVESTIGATION, X-NO SAMPLE RETURNED, AND X-REVIEW DHR. ANALYSIS AND FINDINGS: 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, TRUMBULL AND THE ASSEMBLY ITSELF IS MANUFACTURED BY AN OUTSIDE VENDOR FOR COOPER SURGICAL. REVIEW OF COOPER SURGICAL INCOMING INSPECTION RECORDS NOTED THAT THE VENDOR LOT AND PART NUMBER WERE 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. CORRECTION AND/OR CORRECTIVE ACTION: NONE REASON; CORRECTIVE ACTION IS NOT APPLICABLE AS THE AFFECTED SAMPLE WAS NOT RETURNED FOR INVESTIGATIVE ANALYSIS. REVIEW OF THE LOT DHR BOTH AT COOPER SURGICAL AND BATES INDUSTRIES HAS INDICATED THAT THERE WERE NO ABNORMALITIES. THIS COMPLAINT WILL BE MONITORED FOR TRENDING IN THAT NO INJURY WAS REPORTED TO END USER, OR PATIENT. WAS THE COMPLAINT CONFIRMED? NO.

    Description of Event or Problem · 0

    "CATHETER TUBE WAS BROKEN AT THE TIP WITH EXCESS MECHANICAL STRENGTH BY A SURGEON DURING THE OPERATION. AS THE COMPLIANT PRODUCT WAS CONTAMINATED WITH BLOOD, IT WAS DISCARDED. HE WANTS TO KNOW THE PERMITTED STRENGTH."

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    "CATHETER TUBE WAS BROKEN AT THE TIP WITH EXCESS MECHANICAL STRENGTH BY A SURGEON DURING THE OPERATION. AS THE COMPLIANT PRODUCT WAS CONTAMINATED WITH BLOOD, IT WAS DISCARDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336338 KRONNER MANIPUJECTOR KRONNER MANIPUJECTOR HES COOPERSURGICAL, INC. 6003 226203

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention