BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SFXSPI MCL+ BI UD 6IN2 3-0 DA RB-1

    MDR report key: 22435655 · Received July 8, 2025

    Report

    Report Number
    2210968-2025-07929
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 8, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031464421
    PMA / PMN Number
    K192580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, 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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN ¿ BOTH PATIENTS REQUIRED PROLONGED CATHETERIZATION AND RECURRENT CT CYSTOGRAMS BEFORE TOV PATIENT STATUS/ OUTCOME / CONSEQUENCES, ONE PATIENT CURRENTLY WITH IDC INSITU, ONE PATIENT HAS RECOVERED AS WAS LAST YEAR ¿ HAD IDC IN FOR ALMOST 3 MONTHS WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, CT GUIDED DRAIN AND IDC FOR ONE PATIENT, IDC FOR SECOND PATIENT ¿ BOTH HAVE HAD SEVERAL CT CYSTOGRAMS, ANTIBIOTICS. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE BOTH MEN IN 50¿S FIT AND NOT OBESE. DATE AND NAME OF INDEX SURGICAL PROCEDURE? RALP + BILAT PLND IN (B)(6) 2024 AND RALP (B)(6) 2025. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? PROSTATE CANCER WHAT WAS THE INITIAL APPROACH FOR THE INDEX SURGICAL PROCEDURE? (OPEN, LAPAROSCOPIC OR OTHER)? ROBOTIC. WHAT WAS THE TISSUE CONDITION (NORMAL, THIN, CALCIFIED, FRAGILE, DISEASED)?NORMAL PLEASE DESCRIBE ANASTOMOSIS TECHNIQUE? CONTINUOUS DOUBLE ARMED 3-0 STRATAFIX PLEASE DESCRIBE THE APPEARANCE OF THE SUTURE OBSERVED DURING LEAK? DID NOT VISUALIZE THE SUTURE? THIS WAS 3 WEEKS POST SURGERY NOT AT THE TIME OF SURGERY. DID THE STRATAFIX SUTURE BREAK? IF SO, WHERE WAS THE BREAK NOTED (TERMINATION, MIDDLE, END)? DID THE SUTURES BARBS NOT ENGAGE IN THE TISSUE? DID THE SUTURE PULL OUT OF THE TISSUE? WERE THERE ANY PATIENT STRESS FACTORS THAT PRECIPITATED THE EVENT OF THE LEAK? WERE THERE ANY PRECIPITATING STRESS FACTORS THAT LED TO THE EVENT OF THE LEAK? DID THE OPERATING SURGEON OBSERVE ANY SUTURE DEFICIENCY OR ANOMALY BEFORE, DURING, AFTER THE SUTURE PLACEMENT OR DURING ANY RE-OPERATION? NO WHAT SYMPTOMS DID THE PATIENT EXPERIENCE FOLLOWING THE INDEX SURGICAL PROCEDURE? ONSET DATE? BOTH HEMATURIA 3 WEEKS POST SURGERY ¿ LEAK FOUND ON CT OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? I STRONGLY SUSPECT THE CHANGE IN FORMULATION WITH DECREASED TENSILE STRENGTH HAS LED TO THIS RARE OCCURENCE. WHAT IS THE PATIENT'S CURRENT STATUS?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RALP PROCEDURE IN (B)(6) 2025 AND BARBED SUTURE WAS USED. THE PATIENT EXPERIENCED BLADDER NECK ANASTOMOSIS LEAKING. THE SAME TECHNIQUE HAS BEEN USED WITH THIS NEW SUTURE COMPARED TO A DIFFERENT ONE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072418 SFXSPI MCL+ BI UD 6IN2 3-0 DA RB-1 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ETHICON INC. 10705031464421

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention