BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE SUTURE 30"(75CM) 2-0 BLU

    MDR report key: 20042985 · Received August 22, 2024

    Report

    Report Number
    2210968-2024-08841
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031021037
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE NEEDLE AND ONE SUTURE PIECE OUTSIDE ITS PACKAGING WERE RETURNED FOR ANALYSIS. PRODUCT CODE 8833H. DURING THE VISUAL INSPECTION OF THE DETACHED NEEDLE, MARKS THAT APPEAR TO BE CAUSED BY A SURGICAL INSTRUMENT WERE OBSERVED ON THE BODY AND EDGE OF THE NEEDLE. IN THE HOLE WAS OBSERVED WITH SUTURE REMNANT. THE SUTURE PIECE WAS EXAMINED AND THE END WAS NOTED TO BE CUT PROBABLY CAUSED BY A SURGICAL INSTRUMENT. BESIDES THAT, DAMAGE (CRUSHED) WAS FOUND ON THE SUTURE SURFACE. PER THE CONDITIONS OF THE RETURNED SAMPLE, THE FUNCTIONAL TEST COULD NOT BE PERFORMED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING CAUTION: AS WITH ANY DEVICE, CARE SHOULD BE TAKEN TO AVOID DAMAGE TO THE STRAND WHEN HANDLING. AVOID THE CRUSHING OR CRIMPING ACTION OF SURGICAL INSTRUMENTS, SUCH AS NEEDLE HOLDERS AND FORCEPS. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LOW ANTERIOR RESECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT HE WAS ALERTED BY SCRUB TECH, THAT THE SURGEON HAD A SUTURE HAD BROKEN DURING A ROBOTIC LAR PROCEDURE. NO PATIENT CONSEQUENCE WAS REPORTED. ONE DEVICE RETURNING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1698424 PROLENE SUTURE 30"(75CM) 2-0 BLU SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. TPBADP 10705031021037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown