BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 18341500 · Received December 15, 2023

    Report

    Report Number
    2210968-2023-09845
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    April 1, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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. 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. 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 THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HTTPS://DOI.ORG/10.1007/S00423-023-02844-1.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC AND ROBOTIC INTRACORPOREAL RESECTION AND END-TO-END ANASTOMOSIS IN LEFT COLECTOMY: A PROSPECTIVE COHORT STUDY ¿ STAGE 2A IDEAL FRAMEWORK FOR EVALUATING SURGICAL INNOVATION. THE MAIN OBJECTIVE OF THE PRESENT STUDY IS TO DEVELOP STAGE 2A OF THE IDEAL FRAMEWORK (DEVELOPMENT) IN THE INTRACORPOREAL RESECTION AND ANASTOMOSIS OF THE LEFT COLECTOMY, EVALUATE ITS SAFETY AND EFFICACY, AND DETERMINE IF THE TECHNIQUE CAN BE PERFORMED WITH BOTH APPROACHES WITH SAFETY IN TERMS OF MORBIDITY AND MORTALITY. BETWEEN MAY 2020 AND MARCH 2022, 79 PATIENTS WITH PATHOLOGY OF THE DESCENDING COLON, SIGMOID COLON, AND UPPER THIRD OF THE RECTUM ABOVE THE PERITONEAL REFLECTION, WHO UNDERWENT A LEFT COLECTOMY, SIGMOIDECTOMY, OR UPPER ANTERIOR RESECTION, WITH RESECTION OF THE INFERIOR MESENTERIC VESSELS AND PRESERVATION OF THE MIDDLE CHOLIC ARTERY BOTH BENIGN AND MALIGNANT ALLOWING A MINIMALLY INVASIVE LAPAROSCOPIC OR ROBOTIC APPROACH WERE INCLUDED IN THE STUDY. THERE WERE 48 MALES AND 31 FEMALES WITH A MEAN AGE OF 67 YEARS. 41 OPERATED VIA LAPAROSCOPY (LAPAROSCOPIC LEFT COLECTOMY: LLC) AND 38 BY ROBOTIC SURGERY (ROBOTIC LEFT COLECTOMY: RLC). DURING THE PROCEDURE IN BOTH GROUPS, THE 0 PROLENE MONOFILAMENT SUTURE (ETHICON) WAS PERFORMED ON A COMPETITOR 29-MM CURVED CIRCULAR STAPLER (MANUFACTURER: B. BRAUN) WITH MULTIPLE KNOTS TO AID ITS MANIPULATION, OF ABOUT 7¿10 CM IN LENGTH SO THAT IT CAN BE PULLED THROUGH THE STAPLE LINE OF THE SECTION OF THE COLON. AFTER THE COMPLETE INSERTION OF THE ANVIL HEAD BEYOND THE SECTION MARK, THE ECHELON FLEX ENDOPATH (ETHICON ENDO-SURGERY), 1.5-MM STAPLE HEIGHT AND 60-MM BLUE RELOAD, IS APPLIED. A STAPLED END-TO-END ANASTOMOSIS WAS PERFORMED USING THE COMPETITOR 29-MM CURVED CIRCULAR STAPLER (MANUFACTURER: B. BRAUN). THE SPECIMEN IS EXTRACTED THROUGH A 3¿5-CM MINI-LAPAROTOMY ADAPTED TO THE SIZE OF THE TUMOR, INSIDE A PLASTIC BAG PROTECTED WITH A DUAL-RING RETRACTOR (MANUFACTURER: APPLIED MEDICAL). REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION (N=5), ORGAN/SPACE SURGICAL SITE INFECTION (N=4), AND INADVERTENT INTESTINAL PERFORATION (N=1). IN CONCLUSION, LAPAROSCOPIC AND ROBOTIC INTRACORPOREAL RESECTION AND ANASTOMOSIS ARE FEASIBLE AND SAFE, AND OBTAIN SIMILAR SURGICAL, POSTOPERATIVE, AND PATHOLOGICAL RESULTS THAN DESCRIBED IN LITERATURE. HOWEVER, MORBIDITY SEEMS TO BE HIGHER IN LAPAROSCOPIC LEFT COLECTOMY GROUP WITH FEWER RELEVANT POSTOPERATIVE COMPLICATIONS. THE RESULTS OF THIS STUDY ENABLE US TO PROCEED TO STAGE 2B OF THE IDEAL FRAMEWORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291547 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention