BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRONNER MANIPUJECTOR BOX

    MDR report key: 4739751 · Received April 29, 2015

    Report

    Report Number
    1216677-2015-00011
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    April 2, 2015
    Report Date
    December 15, 2015
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    LKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER DR. (B)(6): "THE RADIOLOGIST TOLD HIM THE PLASTIC IS 2-3CM IN LENGTH AND BROKEN INTO 3 PIECES. HE HONESTLY DOES NOT KNOW HOW IT COULD HAVE BEEN THE KRONNER BUT HE DOESN'T KNOW WHAT ELSE IT COULD BE. DR. (B)(6) ALSO MENTIONED HE WOULD HAVE BEEN THE ONE TO REMOVE THE MANIPULATOR AND DID NOT NOTICE ANYTHING WRONG. I ASKED HIM IF IT COULD HAVE BEEN MIGRATION OF A DIFFERENT PRODUCT LEFT IN THE ABDOMEN. HE SAID IT THE RADIOLOGIST DID NOT SEE ANYTHING INDICATING MIGRATION AND THAT THE PLASTIC WAS LOCATED INSIDE THE CAVITY OF THE UTERUS. WE BASICALLY CAME TO THE CONCLUSION THAT IT DOES NOT MAKES SENSE FOR IT TO BE THE KRONNER. LUCKILY THE PT IS A DENTIST AND CAN UNDERSTAND HOW SOMETHING LIKE THIS CAN HAPPEN. SHE DOES NOT HAVE ANY SYMPTOM AND DOES NOT WANT TO UNDERGO SURGERY JUST TO REMOVE THE PIECES OF PLASTIC". COOPER SURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. THE DEVICE INVOLVED IN THE COMPLAINT WILL NOT BE RETURNED BY THE CUSTOMER FOR EVAL. ONCE THIS INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY REPORT : INITIATED MANUFACTURER'S INVESTIGATION. NO SAMPLE RETURNED. THE FOLLOWING IS AN ACKNOWLEDGEMENT OF THE REPORTED EVENT; "DR. (B)(6) FROM (B)(6) LEFT ME A VOICEMAIL (B)(6) 2015. HE DID AN ULTRA SOUND ON A PATIENT AND THINKS HE SAW PARTS OF THE KRONNER IN HER FROM AN OPERATION 2YRS AGO. THE PATIENT HAS NO SYMPTOMS AND FEELS FINE." THE REMNANTS OF A PREVIOUS PROCEDURE WERE NOT DEFINITIVELY IDENTIFIED AS STATED IN THE COMPLAINT AND THEREFORE CANNOT BE ASSUMED THAT THEY ARE FROM A USED CSI PRODUCT. NORMAL INVASIVE MEDICAL PROCEDURE PROTOCOLS CALLS FOR AN INVENTORY OF MATERIALS AND DEVICES USED IN THE PROCEDURE, AND THEIR PHYSICAL STATE AND COMPLETENESS, IT MAY BE DEDUCED FROM THE COMPLAINT STATEMENT THAT THIS TYPE OF PROTOCOL WAS NOT PRACTICED FOR THE OLDER TWO YEAR OLD PROCEDURE. A REVIEW OF THE KRONER INSPECTION OR LOT DHR RECORDS COULD NOT BE REVIEWED AS THE LOT INFORMATION WAS REPORTED AS UNKNOWN. CORRECTIVE ACTION IS NOT APPLICABLE AS THE AFFECTED SAMPLE IS NOT BEING RETURNED FOR INVESTIGATIVE ANALYSIS, ROOT CAUSE IS INDETERMINABLE. 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

    "DR. (B)(6) FROM (B)(6) LEFT ME A VOICEMAIL (B)(6) 2015. HE DID AN ULTRA SOUND ON A PT AND THINKS HE SAW PARTS OF THE KRONNER IN HER FROM AN OPERATION 2 YRS AGO. THE PT HAS NO SYMPTOMS AND FEELS FINE". (B)(4).

    Description of Event or Problem · 1

    "DR. (B)(6) DID AN ULTRASOUND ONA PATIENT AND THINKS HE SAW PARTS OF TE KRONNER IN HER FROM AN OPERATION 2 YEARS AGO. THE PATIENTS HAS NO SYMPTOMS AND FEELS FINE." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282509 KRONNER MANIPUJECTOR BOX KRONNER MANIPUJECTOR BOX HUMI LKF COOPERSURGICAL, INC. 6003 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other