BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BLK 30IN 2-0 S/A SH

    MDR report key: 18437915 · Received January 3, 2024

    Report

    Report Number
    2210968-2024-00069
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    December 7, 2023
    Report Date
    January 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    UDI-DI
    10705031044388
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). DATE SENT TO THE FDA: 1/3/2024. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? NOT THAT HAS BEEN REPORTED. WERE THERE ANY PATIENT CONSEQUENCES? NOT THAT HAS BEEN REPORTED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLEEVE GASTRECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY WITH HIATAL HERNIA REPAIR PROCEDURE THAT THE SCRUB TECH HANDED OFF THE SUTURE TO THE DR TO GO INTO THE 8MM TROCAR THAT AFTER THE SUTURE WAS PULLED THROUGH THERE WAS NO NEEDLE ON THE SUTURE. AN X-RAY WAS DONE AND SHOWED THE NEEDLE POSSIBLY NEXT TO THE SPLEEN. AFTER THE X-RAY BUT BEFORE CLOSURE THE NEEDLE WAS FOUND IN THE CLEAR CANULA OF THE TROCAR AND WAS NEVER INSIDE THE PATIENT. PROCEDURE WAS EXTENDED BY ABOUT THIRTY MINUTES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492257 SILK BLK 30IN 2-0 S/A SH SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. TJBERR 10705031044388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown