BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 11894131 · Received May 27, 2021

    Report

    Report Number
    2210968-2021-05031
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    November 23, 2018
    Report Date
    May 10, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE NOT RETURNED. THIS REPORT IS RELATED TO A JOURNAL ARTICLE THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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 AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCT (SURGICEL) INVOLVED CAUSED AND/OR CONTRIBUTED TO ACUTE PULMONARY EMBOLUS AND DEATH DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THAT ETHICON PRODUCTS (SURGICEL, VICRYL SUTURE AND LAPRA-TY ABSORBABLE SUTURE CLIP) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE COMPLICATIONS (PSEUDOANEURYSM, FEVER, WOUND DEHISCENCE, SEPSIS AND BLEEDING) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (SURGICEL, VICRYL SUTURE AND LAPRA-TY SUTURE CLIP) USED IN THIS PROCEDURE/STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE EXPIRED PATIENT AND PATIENTS EXPERIENCED POST-OPERATIVE COMPLICATIONS (PSEUDOANEURYSM, FEVER, WOUND DEHISCENCE, SEPSIS AND BLEEDING) AND DETAILS OF EVENTS IF AVAILABLE. WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. WOULD THE AUTHOR/SURGEON LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THESE EVENTS? CITATION: UROLOGY (2019); 126: 102-109. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: COMPARING OFF-CLAMP AND ON-CLAMP ROBOT-ASSISTED PARTIAL NEPHRECTOMY: A PROSPECTIVE RANDOMIZED TRIAL. AUTHORS: BARRETT G. ANDERSON, AARON M. POTRETZKE, KEFU DU, JOEL M. VETTER, KARLA BERGERON, ALETHEA G. PARADIS, AND R. SHERBURNE FIGENSHAU. CITATION: UROLOGY (2019); 126: 102-109. HTTPS://DOI.ORG/10.1016/J.UROLOGY.2018.11.053. THIS PROSPECTIVE RANDOMIZED TRIAL IS TO DETERMINE WHETHER PERFORMING ROBOT-ASSISTED PARTIAL NEPHRECTOMY WITHOUT WARM ISCHEMIA ¿OFF-CLAMP¿ RESULTS IN FAVORABLE POSTOPERATIVE RENAL FUNCTIONAL OUTCOMES COMPARED WITH THE ON-CLAMP METHOD. BETWEEN 2013 TO 2017, A TOTAL OF 80 PATIENTS WITH A SMALL RENAL MASS UNDERWENT ROBOT-ASSISTED PARTIAL NEPHRECTOMY (RAPN). 40 PATIENTS (72.5% MALE AND 27.5% FEMALE; MEAN AGE = 59.4 YEARS; MEAN BMI = 31.6) WERE RANDOMIZED TO THE ON-CLAMP GROUP AND 40 PATIENTS (55% MALE AND 45% FEMALE; MEAN AGE = 56.6 YEARS; MEAN BMI = 32.4) TO THE OFF-CLAMP GROUP. SURGERY WAS PERFORMED IN THE ON-CLAMP GROUP BY USING COMPETITOR DEVICES, AND AN INTERRUPTED 0 VICRYL (ETHICON) TO REAPPROXIMATE THE RENAL CAPSULE AND LAPRA-TY CLIPS (ETHICON) TO SECURE ITS PLACE. IN THE OFF-CLAMP GROUP, SURGICEL (ETHICON) OR OTHER METHOD WAS USED IF BRISK BLEEDING WAS ENCOUNTERED. REPORTED COMPLICATIONS INCLUDED DEATH SECONDARY TO ACUTE PULMONARY EMBOLUS (N=1) ON THE FIRST POSTOPERATIVE DAY; 30-D COMPLICATION RATE (N=?); 30-D MAJOR COMPLICATION RATE (N=?); PSEUDOANEURYSM (N=2); FEVER (N=1); POSTOPERATIVE BLEEDING (N=2) REQUIRING BLOOD TRANSFUSION IN ONE PATIENT IN THE ON-CLAMP GROUP WHILE BLOOD TRANSFUSION AND EMBOLIZATION IN ONE PATIENT IN THE OFF-CLAMP GROUP; WOUND DEHISCENCE (N=1); AND SEPSIS (N=1). IN CONCLUSION, IN PATIENTS WITH NORMAL RENAL FUNCTION, THERE IS INSUFFICIENT EVIDENCE TO SUGGEST THAT OFF-CLAMP RAPN RESULTS IN LESS RENAL FUNCTIONAL LOSS WHEN COMPARED WITH THE ON-CLAMP TECHNIQUE. OTHER PERIOPERATIVE OUTCOMES ARE COMPARABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794294 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention