BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*5MM GRASPER

    MDR report key: 15469929 · Received September 23, 2022

    Report

    Report Number
    3005075853-2022-06340
    Event Type
    Injury
    Date Received
    September 23, 2022
    Date of Event
    August 29, 2022
    Report Date
    March 10, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    MDM
    UDI-DI
    10705036000792
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: UNKNOWN, CAPTURED AS AWARENESS DATE. BATCH # UNK. 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/BATCH NUMBER HAS NOT BEEN PROVIDED. 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 THE ETHICON DEVICES ENDOPATH*5MM GRASPER AND ENSEAL CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN." 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Additional Manufacturer Narrative · 0

    PC-(B)(4). DATE SENT: 3/10/2023 H6. HEALTH EFFECT - CLINICAL CODE H6. HEALTH EFFECT - IMPACT CODE H6. HEALTH EFFECT - CLINICAL CODE H6. HEALTH EFFECT - IMPACT CODE

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE; TITLE: HYSTERECTOMY AND ADNEXAL PROCEDURES BY VAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (VNH): INITIAL FINDINGS FROM A KOREAN SURGEON AUTHOR: MYEONG-SEON KIM, JOSEPH J. NOH AND TAE-JOONG KIM CITATION: KIM M-S, NOH JJ AND KIM T-J (2021) HYSTERECTOMY AND ADNEXAL PROCEDURES BY VAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (VNH): INITIAL FINDINGS FROM A KOREAN SURGEON. FRONT. MED. 7:583147. DOI: 10.3389/FMED.2020.583147. THE OBJECTIVE OF THIS STUDY IS TO EVALUATE FEASIBILITY AND SAFETY OF HYSTERECTOMY AND ADNEXAL PROCEDURES BY VAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (VNOTES). FROM APRIL 2018 TO JUNE 2019, A TOTAL OF 34 FEMALE PATIENTS UNDERWENT VNOTES USING SUCTION AND IRRIGATOR, SHORT GRASPER (ENDOPATH GRASPER 5MM, ETHICON US, LLC), AND ENSEAL G2 TISSUE SEALER (45 CM LENGTH AND CURVED TIP, ETHICON US, LLC). ONE PATIENT UNDERWENT TRANSUMBILICAL SINGLE-PORT SURGERY BECAUSE OF LATE-ONSET POSTOPERATIVE BLEEDING ON THE 13TH POSTOPERATIVE DAY. ALTHOUGH THERE WERE THREE COMPLICATIONS, VNOTES OFFERS ADVANTAGES TO PATIENTS AND SURGEONS. MORE SURGICAL TECHNIQUES WILL BE DEVELOPED IN VNOTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776068 ENDOPATH*5MM GRASPER RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS, SINGLE-USE MDM ETHICON ENDO-SURGERY, LLC. 5DSG 10705036000792

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention