BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18788718 · Received February 27, 2024

    Report

    Report Number
    2210968-2024-01958
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    February 1, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    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. AN ATTEMPT HAS BEEN 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED H6 CLINICAL CODE: E2402 ¿ POSTOPERATIVE COMPLICATIONS GRADE I AND II THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: ANN SURG (FEB 2022);275(2):E433¿E442. DOI: 10.1097/SLA.0000000000004067 PLEASE SEE ARTICLE ATTACHED.

    Description of Event or Problem · 0

    TITLE: OUTCOMES OF ROBOTIC LIVING DONOR RIGHT HEPATECTOMY FROM 52 CONSECUTIVE CASES COMPARISON WITH OPEN AND LAPAROSCOPY-ASSISTED DONOR HEPATECTOMY THE AIM OF THISRETROSPECTIVE STUDY IS TO EVALUATE NOT ONLY THE FEASIBILITY AND SAFETY OF ROBOTIC LIVING DONOR RIGHT HEPATECTOMY (RLDRH) IN A RELATIVELY LARGE NUMBER OF CASES BUT ALSO DONOR SATISFACTION OF A PURE MINIMALLY INVASIVE APPROACH COMPARED WITH CONVENTIONAL OPEN DONOR RIGHT HEPATECTOMY (CODRH) AND LAPAROSCOPY-ASSISTED DONOR RIGHT HEPATECTOMY (LADRH). FROM MARCH 2016 TO MARCH 2019, 52 LIVER DONORS (26 MALE AND 26 FEMALE; MEAN AGE OF 28.6±8.7 YEARS) UNDERWENT RLDRH. THE CLINICAL AND PERIOPERATIVE OUTCOMES OF RLDRH WERE COMPARED WITH THOSE OF CODRH (N=62; 39 MALE AND 23 FEMALE; MEAN AGE OF 28.7±8.3 YEARS) AND LADRH (N=118; 74 MALE AND 44 FEMALE; MEAN AGE OF 36.9±12.1 YEARS). DURING THE RLDRH PROCEDURE, THE RIGHT HEPATIC ARTERY AND RIGHT PORTAL VEIN WERE ISOLATED AND CONNECTED TO A VASCULAR LOOP DURING HILAR DISSECTION. THE DIVISION LINE OF THE RIGHT PORTAL VEIN WAS MARKED USING 6-0 PROLENE SUTURE ON THE RIGHT SIDE OF THE PORTAL VEIN BIFURCATION. PARENCHYMAL DISSECTION WAS PERFORMED WITH THE ROBOTIC HARMONIC SCALPEL IN THE LEFT HAND AND A MARYLAND BIPOLAR FORCEPS IN THE RIGHT HAND. THE HARMONIC SCALPEL TRANSECTED THE LIVER PARENCHYMA WITH SMALL BITES AND THE MARYLAND BIPOLAR FORCEPS WERE USED TO DISSECT THE PARENCHYMA, SIMILAR TO THE CLAMP-CRUSH TECHNIQUE IN OPEN SURGERY. REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE COMPLICATIONS GRADE I (N=6) AND II (N=4). IN CONCLUSION, RLDRH RESULTED IN LESS BLOOD LOSS COMPARED WITH THAT OF CODRH AND SIMILAR POSTOPERATIVE COMPLICATION RATES TO CODRH AND LADRH. RLDRH PROVIDED BETTER BODY IMAGE AND COSMETIC RESULTS COMPARED WITH THOSE OF LADRH. RLDRH IS FEASIBLE AND SAFE WHEN PERFORMED BY SURGEONS EXPERIENCED WITH BOTH ROBOTIC AND OPEN HEPATECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668609 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention