BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT

    MDR report key: 20008422 · Received August 20, 2024

    Report

    Report Number
    2210968-2024-08626
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    February 10, 2022
    Report Date
    August 16, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    FZP
    PMA / PMN Number
    K931492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: OKUBO ET AL. BMC RESEARCH NOTES (2022) 15:332, HTTPS://DOI.ORG/10.1186/S13104-022-05922-7.

    Description of Event or Problem · 0

    TITLE: ESD-AID SURGERY AS A NEW TREATMENT STRATEGY FOR DUODENAL ADENOMA. THIS STUDY REPORTED THE UTILITY AND SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION-AID SURGERY AS A NEW CONCEPT OF TREATMENT FOR DUODENAL ADENOMA. FROM APRIL 2018 TO DECEMBER 2020, 13 PATIENTS WITH DUODENAL ADENOMA WHO UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION-AID SURGERY WERE INCLUDED IN THE STUDY. THERE WERE 11 MALES AND 2 FEMALES WITH A MEAN AGE OF 67 YEARS (RANGE, 47¿82). DURING THE PROCEDURE, AFTER MOBILIZING THE HEPATIC FLEXURE OF THE COLON, KOCHER MOBILIZATION WAS PERFORMED FROM THE SECOND TO THE THIRD PART OF THE DUODENUM, DEPENDING ON THE TUMOR LOCATION. TUMOR INCISION WAS CONFIRMED LAPAROSCOPICALLY AND ENDOSCOPICALLY. USING ABSORBENT THREADS AND SUTURE CLIPS (LAPRA-TY®, ETHICON), A SEROMUSCULAR SUTURE WAS APPLIED TO THE DUODENUM ALONG THE LONG AXIS IN ORDER TO DRAW THE SCAR PORTION OF THE TUMOR CLOSER. THE ABDOMINAL CAVITY WAS WASHED, AND THE ABSENCE OF BLEEDING WAS CONFIRMED BEFORE DRAIN PLACEMENT AND WOUND CLOSURE. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING (N=1). IN CONCLUSION, USING THE ADVANTAGES OF ENDOSCOPY AND LAPAROSCOPY, ENDOSCOPIC SUBMUCOSAL DISSECTION-AID -AID SURGERY MAY BE CONSIDERED A SAFE AND MINIMALLY INVASIVE TREATMENT FOR DUODENAL ADENOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008610 LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT CLIP, IMPLANTABLE FZP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention