BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERS TAPE WHT 12INX3/16IN D/A CTX

    MDR report key: 11668784 · Received April 14, 2021

    Report

    Report Number
    2210968-2021-03382
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 19, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    KDC
    UDI-DI
    10705031049802
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT: (B)(4). COMPONENT CODE: (B)(4) DEVICE NOT RETURNED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER PKP116 / ENRS2246, AND NO NON-CONFORMANCE'S RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. SUMMARY: THE PRODUCT WAS NOT RETURNED TO ETHICON INC FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE PICTURES RECEIVED. VISUAL ANALYSIS OF THE TWO PICTURES RECEIVED DETERMINED THAT A SEALED SAMPLE OF PRODUCT CODE ES22 COULD BE OBSERVED. THE REPORTED CONDITION COULD NOT BE OBSERVED IN THE PICTURE. NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE REPORTED COMPLAINT SINCE THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT WAS USED TO COMPLETE THE PROCEDURE? A NEW SUTURE OF THE SAME CODE WAS USED TO COMPLETE THE PROCEDURE DID THE NEEDLE FELL INSIDE THE PATIENT WHEN IT SEPARATED FROM THE SUTURE? IF YES, HOW WAS IT RETRIEVED? FOR EXAMPLE, SWITCHED TO AN OPEN PROCEDURE, SECOND SURGERY?- THE NEEDLE WAS INSIDE THE PATIENT WHEN IT WAS PULLED AWAY FROM THE SUTURE MATERIAL. THE NEEDLE WAS REMOVED THROUGH THE TROCAR. COULD YOU PLEASE CONFIRM THE DEVICE'S (OR A SAMPLE FROM THE SAME LOT) AVAILABILITY FOR RETURN ? IF AVAILABLE, PLEASE PROVIDE THE DEVICE RETURN STATUS/FOLLOW UP. SAMPLE IS AVAILABLE. (ANOTHER THREAD FROM THIS BATCH). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC "CIRCLING"/CERCLAGE PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED. DURING THE SURGERY, AT THE STAGE OF SUTURING ON THE EXTERNAL CERVICAL OS, THE NEEDLE SEPARATED FROM THE SUTURE MATERIAL. THE NEEDLE WAS INSIDE THE PATIENT WHEN IT WAS PULLED AWAY FROM THE SUTURE MATERIAL. THE NEEDLE WAS REMOVED THROUGH THE TROCAR. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ANOTHER LIKE SUTURE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560830 MERS TAPE WHT 12INX3/16IN D/A CTX CLASS I DEVICE - EXEMPT KDC ETHICON INC. RS22 PKP116 10705031049802

    Patients

    Seq Age Sex Outcome Treatment
    1