BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PDSII VIO 30IN USP5-0

    MDR report key: 19574229 · Received June 20, 2024

    Report

    Report Number
    2210968-2024-06407
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    May 10, 2024
    Report Date
    July 18, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031113411
    PMA / PMN Number
    N18331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THERE ANY PATIENT CONSEQUENCES AS A RESULT OF THE EVENT? NO PATIENT CONSEQUENCES. D4: UDI: AS THE SERIAL NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THERE ANY PATIENT CONSEQUENCES AS A RESULT OF THE EVENT? TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A CHOLECYSTECTOMY + ABLATION OF CALCULES IN THE BILIAL WAYS BY COELIOSCOPY ON (B)(6) 2024 AND SUTURE WAS USED. TWO SUTURES WERE USED DURING THE PROCEDURE. IN ORDER TO BE USED, THEY WERE CUT IN TWO WITH A NEEDLE ON EACH SIDE IN ORDER TO AFFECT A LAPAROSCOPIC OVERJET OF THE CYSTIC CANAL. ONE NEEDLE OF THE FOUR BECAME DEFORMED AND ANOTHER NEEDLE PULLED OFF. THE SUTURES HAD BEEN STORED IN THE OPERATING ROOM, THEREFORE HYDROMETRY AND TEMPERATURE WERE CONTROLLED. THE NEEDLES COULD BE REMOVED, AND ANOTHER PDS SUTURE WAS USED. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512077 PDSII VIO 30IN USP5-0 SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. SJMMEJ 10705031113411

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown