BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT

    MDR report key: 22546036 · Received July 18, 2025

    Report

    Report Number
    2210968-2025-08362
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    April 12, 2024
    Report Date
    July 18, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    FZP
    PMA / PMN Number
    K931492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: UROL ONCOL. 2024 JUL;42(7):222.E1-222.E7. HTTPS://DOI.ORG/10.1016/J.UROLONC.2024.03.004 EPUB 2024 APR 12. PMID: 38614921.

    Description of Event or Problem · 0

    TITLE: TIMING, INCIDENCE AND MANAGEMENT OF DELAYED BLEEDING AFTER PARTIAL NEPHRECTOMY IN PATIENTS AT RISK FOR RECURRENT, BILATERAL, MULTIFOCAL RENAL TUMORS. THE OBJECTIVE OF THIS RETROSPECTIVE STUDY OF A PROSPECTIVELY MAINTAINED DATABASE WAS TO EVALUATE THE INCIDENCE AND TIMING OF DELAYED BLEEDING AS WELL AS THE IMPACT OF INTERVENTION ON RENAL FUNCTIONAL OUTCOMES IN A COHORT PRIMARILY MADE UP OF PATIENTS AT RISK FOR BILATERAL, MULTIFOCAL RENAL TUMORS. BETWEEN 2003 AND 2023, A TOTAL OF 844 PATIENTS WHO UNDERWENT A TOTAL OF 1,256 PARTIAL NEPHRECTOMY WERE INCLUDED IN THE STUDY. A TOTAL OF 5,501 TUMORS REMOVED. RENORRAPHY IS PERFORMED IN 2 LAYERS WITH A SINGLE SUTURE TO RUN THE BASE OF THE DEFECT FOLLOWED BY STANDARD CAPSULAR CLOSURE WITH ABSORBABLE SUTURE SECURED WITH LAPRA-TY (ETHICON) AND HEM-O-LOK (WECK) CLIPS. IF INDIVIDUAL VESSELS ARE SEEN, THEY ARE CONTROLLED WITH A COMBINATION OF BIPOLAR CAUTERY AND SUTURE LIGATION. INJECTABLE HEMOSTATIC AGENTS, ARE FREQUENTLY PLACED IN THE RENORRHAPY AND THE USE OF BOLSTER IS AT THE DISCRETION OF THE SURGEON. REPORTED COMPLICATIONS INCLUDE: (N=3) ASYMPTOMATIC EVIDENCE OF PSEUDOANEURYSM TREATMENT: SUBSEQUENT ELECTIVE ANGIOEMBOLIZATION PERFORMED AT A MEDIAN OF 84 DAYS POSTOPERATIVELY. (N=21) ACUTE SYMPTOMS OF BLEEDING, INCLUDING WITH GROSS HEMATURIA IN 13 (54.2%), DECREASING HEMOGLOBIN IN 4(16.7%), FLANK PAIN IN 2(8.3%), AND MENTAL STATUS CHANGE IN 2 (8.3%). TREATMENT: EMBOLIZATION WAS PERFORMED. FOURTEEN PATIENTS (58.3%) WERE TRANSFUSED AT THE TIME OF PRESENTATION. A 47-YEAR-OLD FEMALE (N=1): ON POD#6, SHE DEVELOPED NEW ACUTE FLANK PAIN AND HYPOTENSION. TREATMENT: HER HYPOTENSION RESPONDED TO A FLUID BOLUS AND SHE WAS TAKEN FOR A CT WITHOUT CONTRAST DUE TO CONTRAST ALLERGY WITHOUT TIME FOR PRE-MEDICATION. AXIAL CT IMAGE DEMONSTRATING A PERINEPHRIC COLLECTION WITH VARYING DENSITIES SUGGESTING OLD AND NEW BLOOD PRODUCTS. CORONAL IMAGE OF PERINEPHRIC HEMATOMA AND DEPENDENT LAYERING HIGH DENSITY MATERIAL SUGGESTING ACUTE BLEEDING. TREATMENT: UNDERWENT EMBOLIZATION. IN CONCLUSION, DELAYED BLEEDING AFTER PN IN A COHORT OF PATIENTS WITH MULTIFOCAL TUMORS IS AN INFREQUENT EVENT, WITH SIMILAR RATES TO SINGLE TUMOR SERIES. PATIENTS SHOULD BE COUNSELED REGARDING TIMING AND SYMPTOMS OF DELAYED BLEEDING AND MULTIDISCIPLINARY MANAGEMENT WITH INTERVENTIONAL RADIOLOGY IS CRITICAL FOR TIMELY DIAGNOSIS AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303722 LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT CLIP, IMPLANTABLE FZP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention