BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 15747270 · Received November 7, 2022

    Report

    Report Number
    2210968-2022-09197
    Event Type
    Death
    Date Received
    November 7, 2022
    Date of Event
    October 27, 2021
    Report Date
    November 7, 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
    IT
    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/DEATH 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? WOULD THE JOURNAL AUTHOR /PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-09196, 2210968-2022-09198. CITATION CITE: SURGICAL ENDOSCOPY (2022) 36:4417¿4428. HTTPS://DOI.ORG/10.1007/S00464-021-08793-4.

    Description of Event or Problem · 0

    TITLE: ROBOT-ASSISTED PANCREATODUODENECTOMY WITH THE DA VINCI XI: CAN THE COSTS OF ADVANCED TECHNOLOGY BE OFFSET BY CLINICAL ADVANTAGES? A CASE-MATCHED COST ANALYSIS VERSUS OPEN APPROACH. THE AIM OF OUR STUDY IS TO PERFORM A STRUCTURED COST-ANALYSIS COMPARING RPD CARRIED OUT WITH THE USE OF THE DA VINCI XI AND TRADITIONAL OPD PERFORMED IN A MULTIDISCIPLINARY ROBOTIC SURGERY CENTER, CONSIDERING HEALTHCARE DIRECT COSTS ASSOCIATED TO THE INTERVENTIONS AND THOSE ASSOCIATED TO THE SHORT-TERM POST-OPERATIVE COURSE. TWENTY RPD AND 194 OPD PERFORMED BETWEEN JANUARY 2011 AND DECEMBER 2020 BY THE SAME OPERATOR AT OUR HIGH-VOLUME MULTIDISCIPLINARY CENTER FOR ROBOT-ASSISTED SURGERY AND FOR PANCREATIC SURGERY, WERE RETROSPECTIVELY ANALYZED. TWO COMPARABLE GROUPS OF 20 PATIENTS (XI-RPD-GROUP) AND 40 PATIENTS (OPD-GROUP) WERE OBTAINED MATCHING 1:2 THE RPD-GROUP WITH THE OPD-GROUP. PERIOPERATIVE DATA AND OVERALL COSTS, INCLUDING OVERALL VARIABLE COSTS (OVCS) AND FIXED COSTS, WERE COMPARED. 5¿0 POLYESTER (PDS, ETHICON, INC., NJ) AND 5¿0 POLYPROPYLENE. (PROLENE; ETHICON, INC., NJ) SUTURES WERE USED. REPORTED COMPLICATIONS INCLUDED CLAVIEN DINDO III (N=7), GRADE B POST-OPERATIVE PANCREATIC FISTULA (N=4), (N=7), BIOCHEMICAL LEAK (N=10), DEATH (N=1) DUE TO GRADE C POST-OPERATIVE PANCREATIC FISTULA, BILE LEAK (N=1), POST-OPERATIVE DIGESTIVE HEMORRHAGE (N= 3), ABDOMINAL COLLECTION (N= 10), IN CONCLUSION ROBOT-ASSISTED SURGERY IS MORE EXPENSIVE BECAUSE OF HIGHER ACQUISITION AND MAINTENANCE COSTS. HOWEVER, ALTHOUGH RPD IS ASSOCIATED TO HIGHER MATERIAL COSTS, THE ADVANTAGES OF THE ROBOTIC SYSTEM ASSOCIATED TO LOWER HOSPITAL STAY COSTS AND THE ABSENCE OF DIFFERENCE IN TERMS OF PERSONNEL COSTS THANKS TO THE SIMILAR OPERATIVE TIME WITH RESPECT TO OPD, MAKE THE OVCS OF THE TWO TECHNIQUES NO LONGER DIFFERENT. HENCE, THE HIGHER COSTS OF ADVANCED TECHNOLOGY CAN BE PARTIALLY COMPENSATED BY CLINICAL ADVANTAGES, PARTICULARLY WITHIN A HIGH-VOLUME MULTIDISCIPLINARY CENTER FOR BOTH ROBOT-ASSISTED AND PANCREATIC SURGERY. THESE PRELIMINARY DATA NEED CONFIRMATION BY FURTHER STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250461 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| R