BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURESTRAP UNKNOWN PRODUCT

    MDR report key: 15252266 · Received August 18, 2022

    Report

    Report Number
    2210968-2022-06754
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    July 1, 2022
    Report Date
    August 18, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GDW
    PMA / PMN Number
    K093845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INGUINAL HERNIORRHAPHY BY VIDEO ON (B)(6) 2022 AND THE ABSORBABLE STRAP WAS USED. IT WAS REPORTED THAT THE MATERIAL HAS FAILED, INCREASING THE SURGICAL TIME. IT WAS REPORTED THAT BLEEDING OCCURS DURING THE APPLICATION OF THIS CLIP. THE CLIP IS HOOK-SHAPED AND ENTERS WITH PRESSURE, OFTEN CAUSING LOCAL BLEEDING. AND IN THE LATTER, THE BLEEDING WAS INTENSE, REQUIRING HEMOSTASIS WITH CLIPS. IT WAS REPORTED THAT THE STAPLER IS NOT COMPATIBLE WITH MICROPOROUS SCREENS, AS THE MESH OF THE SCREEN IS SO DENSE THAT THE CLIP DOES NOT GO THROUGH AND THE SCREEN IS LOOSE, INCREASING THE CHANCE OF HERNIA RECURRENCE. IT WAS REPORTED THAT THE MACROPOROUS SCREEN IS ALWAYS CONSIDERED. IT WAS ALSO REPORTED THAT BECAUSE OF THE MATERIAL, A SURGERY THAT WOULD TAKE FIFTY MINUTES AND WOULD NOT HAVE ANY COMPLICATIONS, TOOK ALMOST TWO HOURS AND THERE WAS STILL MASSIVE BLEEDING THAT COULD COMPROMISE THE PATIENT'S STABILITY. IT WAS ALSO REPORTED THAT IT IS UNFEASIBLE TO USE THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026312 SECURESTRAP UNKNOWN PRODUCT IMPLANTABLE STAPLE GDW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention