BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 25157035 · Received May 13, 2026

    Report

    Report Number
    2955842-2026-24731
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    July 8, 2025
    Report Date
    April 14, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. NOTE: THIS MEDWATCH REPORT (MDR) IS FOR THE PATIENT THAT REQUIRED CONVERSION TO OPEN DISTAL PANCREATECTOMY FOLLOWING MASSIVE HEMORRHAGE SECONDARY TO DISLODGEMENT OF A HEM-O-LOK CLIP DURING VASCULAR CONTROL. REFER TO MDR WITH MFR. REPORT #2955842-2026-24630 FOR MDR SUBMISSION OF THE OTHER 16 PATIENTS WHO EXPERIENCED POST-OPERATIVE COMPLICATIONS (I.E. PANCREATIC FISTULA COMPLICATIONS AND ABDOMINAL INFECTIONS) REQUIRING MEDICAL INTERVENTION. CITATION: ZHANG J, ET. AL.,. STANDARD OPERATING PROCEDURES AND LEARNING CURVE ANALYSIS FOR SURGICAL ASSISTANTS IN ROBOT-ASSISTED DISTAL PANCREATECTOMY. J ROBOT SURG. 2025;19:381. DOI:10.1007/S11701-025-02574-0 HTTPS://DOI.ORG/10.1007/S11701-025-02574-0 SECTION A2: PATIENT AGE REFLECTS THE MEDIAN AGE OF 54 YEARS WITH AGE RANGE STATED AS BETWEEN 34 AND 64 YEARS. SECTION A3A: PATIENT GENDER IS SELECTED AS FEMALE. 70% OF THE PATIENTS IN THE STUDY ARE FEMALE. SECTION A6: PATIENT RACE REPRESENTS THE PATIENTS IN THE ROBOTIC GROUP. SECTION B7: MEDICAL HISTORY REFLECTS THE STUDY POPULATION CO-MORBIDITIES, NOT THE SPECIFIC PATIENT. SECTION D: GENERIC DA VINCI XI SYSTEM PRODUCT INFORMATION NUMBER IS PROVIDED. SECTION E: THE EVENT SITE IS RECORDED BASED ON THE LOCATION OF THE CORRESPONDING AUTHOR'S ASSOCIATED HOSPITAL. SECTION E: SINCE THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY INTUITIVE SURGICAL, INC. (ISI), RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT.

    Description of Event or Problem · 0

    A REVIEW OF AN ARTICLE THAT EVALUATED THE DEVELOPMENT OF STANDARD OPERATING PROCEDURES AND THE LEARNING CURVE FOR SURGICAL ASSISTANTS IN ROBOT-ASSISTED DISTAL PANCREATECTOMY WAS PERFORMED. THE RETROSPECTIVE, SINGLE-CENTER STUDY ANALYZED 91 PATIENTS UNDERGOING DA VINCI-ASSISTED DISTAL PANCREATECTOMY BETWEEN NOVEMBER 2022 AND MARCH 2025. SEVENTEEN PATIENTS EXPERIENCED POST-OPERATIVE ADVERSE EVENTS: 10 PATIENTS EXPERIENCED POSTOPERATIVE PANCREATIC FISTULA COMPLICATIONS AND WERE TREATED WITH CT-GUIDED PERCUTANEOUS DRAINAGE AND/OR SUPPORTIVE/STANDARD POSTOPERATIVE MANAGEMENT; 6 PATIENTS EXPERIENCED ABDOMINAL INFECTION AND WERE TREATED WITH ANTIBIOTICS. ONE PATIENT REQUIRED CONVERSION TO OPEN DISTAL PANCREATECTOMY FOLLOWING MASSIVE HEMORRHAGE SECONDARY TO DISLODGEMENT OF A HEM-O-LOK CLIP DURING VASCULAR CONTROL. MULTIPLE ATTEMPTS TO CONTACT THE CORRESPONDING AUTHOR WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253370 ENDOWRIST CLIP APPLIER NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1