BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 21617828 · Received March 17, 2025

    Report

    Report Number
    2955842-2025-08576
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    August 19, 2024
    Report Date
    February 16, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K183224
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A MEDICAL REVIEW WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) AND THE FOLLOWING INFORMATION WAS PROVIDED: "ACCORDING TO THE LITERATURE, A RECTOVAGINAL FISTULA MAY OCCUR IN AS MANY AS 1.5-5.1% OF ALL LAR CASES FOR RECTAL CANCER IN LARGE SERIES. THIS RELATIVELY COMMON COMPLICATION MAY OCCUR SOON AFTER SURGERY WHICH MAY INDICATE A TECHNICAL ISSUE AT THE TIME OF SURGERY OR DELAYED SEVERAL WEEKS OR MONTHS AFTER THE PROCEDURE. CONFOUNDING VARIABLES INCLUDE SEVERAL PATIENT RELATED TREATMENTS OR COMORBIDITIES INCLUDING SMOKING, VASCULAR DISEASE, RADIATION THERAPY AND MORE. THIS COMPLICATION CAN OCCUR IN ALL METHODS OF LOW ANTERIOR RESECTION (OPEN, LAPAROSCOPIC, OR ROBOTIC) AND REGARDLESS AS TO HOW AN ANASTOMOSIS WAS CONSTRUCTED, EITHER STAPLED OR SUTURED. IN THIS EVENT, THIS PATIENT¿S POTENTIAL CONFOUNDING VARIABLES ARE NOT PROVIDED. MOREOVER, THIS EVENT OCCURRED MANY MONTHS AFTER THE INDEX PROCEDURE AND THE PATIENT¿S HISTORY OR OTHER POTENTIAL MEDICAL ISSUES THAT MAY HAVE HAPPENED DURING THE INTERIM ARE NOT PROVIDED. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT EVIDENCE IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT. 1. LOHSIRIWAT V, JITMUNGNGAN R. RECTOVAGINAL FISTULA AFTER LOW ANTERIOR RESECTION: PREVENTION AND MANAGEMENT. WORLD J GASTROINTEST SURG 2021; 13(8): 764-771 [PMID: 34512900 DOI: 10.4240/WJGS.V13.I8.764] 2. REX JC JR, KHUBCHANDANI IT. RECTOVAGINAL FISTULA: COMPLICATION OF LOW ANTERIOR RESECTION. DIS COLON RECTUM. 1992;35:354-356. [PUBMED] [DOI] 3. MATTHIESSEN P, HANSSON L, SJÖDAHL R, RUTEGÅRD J. ANASTOMOTIC-VAGINAL FISTULA (AVF) AFTER ANTERIOR RESECTION OF THE RECTUM FOR CANCER--OCCURRENCE AND RISK FACTORS. COLORECTAL DIS. 2010;12:351-357. 4. WATANABE J, OTA M, KAWAGUCHI D, SHIMA H, KAIDA S, OSADA S, KAMIMUKAI N, KAMIYA N, ISHIBE A, WATANABE K, MATSUYAMA R, AKIYAMA H, ICHIKAWA Y, OBA M, ENDO I. INCIDENCE AND RISK FACTORS FOR RECTOVAGINAL FISTULA AFTER LOW ANTERIOR RESECTION FOR RECTAL CANCER. INT J COLORECTAL DIS. 2015;30:1659-1666. 5. ZHENG H, GUO T, WU Y, LI C, CAI S, LIU F, XU Y. RECTOVAGINAL FISTULA AFTER LOW ANTERIOR RESECTION IN CHINESE PATIENTS WITH COLORECTAL CANCER. ONCOTARGET. 2017;8:73123-73132. [PUBMED] [DOI] [CITED IN THIS ARTICLE: 6] [CITED BY IN CROSSREF: 16] [CITED BY IN RCA: 17] [ARTICLE INFLUENCE: 2.1] [REFERENCE CITATION ANALYSIS (0)] 6. HUANG MJ, YE DX, LIN Y, LU XR, LIN HM, CHI P, HUANG Y. A NOMOGRAM FOR PREDICTING RECTOVAGINAL FISTULA AFTER LOW ANTERIOR RESECTION FOR RECTAL CANCER. SURG TODAY. 2020;50:1206-1212. [PUBMED] [DOI] [CITED IN THIS ARTICLE: 4] [CITED BY IN CROSSREF: 3] [CITED BY IN RCA: 4] [ARTICLE INFLUENCE: 0.8] [REFERENCE CITATION ANALYSIS (0)] 7. WOO IT, PARK JS, CHOI GS, PARK SY, KIM HJ, LEE HJ. OPTIMAL STRATEGIES OF RECTOVAGINAL FISTULA AFTER RECTAL CANCER SURGERY. ANN SURG TREAT RES. 2019;97:142-148. [PUBMED] [DOI] [CITED IN THIS ARTICLE: 7] [CITED BY IN CROSSREF: 11] [CITED BY IN RCA: 11] [ARTICLE INFLUENCE: 1.8] [REFERENCE CITATION ANALYSIS (0)] 8. BARUGOLA G, BERTOCCHI E, LEONARDI A, ALMOUDARIS AM, RUFFO G. POST SURGICAL RECTOVAGINAL FISTULA: WHO REALLY BENEFITS FROM STOMA DIVERSION? UPDATES SURG. 2021;73:165-171. [PUBMED] [DOI] [CITED IN THIS ARTICLE: 3] [CITED BY IN CROSSREF: 2] [CITED BY IN RCA: 2] [ARTICLE INFLUENCE: 0.4] [REFERENCE CITATION ANALYSIS (0)] JOHN.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. A RETURN MATERIAL AUTHORIZATION (RMA) WAS NOT ISSUED FOR RETURN AS THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS DISPOSED; THEREFORE, FAILURE ANALYSIS CANNOT BE PERFORMED. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED, AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE PLACEMENT OF STAPLE LINES IN THE PELVIC REGION WAS CONFIRMED. THE STAPLE LINES APPEAR NOMINAL AND DO NOT APPEAR TO HAVE ANY ACTIVE BLEEDING OR MALFORMED STAPLES. AN ADVANCE STAPLER LOG REVIEW SHOW THE SUREFORM 45 STAPLER INSTRUMENT (LOT NUMBER: T12221202-0153), WAS INSTALLED ON THE SYSTEM 3 TIMES AND FIRED 3 GREEN RELOADS. ON INSTALLS 1 AND 3, THE FIRST CLAMPS WERE SUCCESSFUL, AND THE FIRINGS WERE EACH COMPLETED WITH NO PAUSES FOR COMPRESSION. ON INSTALL 2, THE SYSTEM FAILED TO DETECT THE RELOAD COLOR, AND THE USER MANUALLY SELECTED THE GREEN 45 RELOAD ACCESSORY ON THE SURGEON SIDE CONSOLE TOUCHPAD. THE FIRST CLAMP WAS SUCCESSFUL, AND THE FIRING WAS COMPLETED WITH 1 PAUSE FOR COMPRESSION. THERE WERE NO STAPLER RELATED ERRORS IN THE LOGS. THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, 6 MONTHS POST-OPERATIVE THE PATIENT WAS FOUND TO HAVE DEVELOPED A RECTOVAGINAL FISTULA. DURING THE PROCEDURE, A SUREFORM 45 STAPLER INSTRUMENT WITH A GREEN RELOAD ACCESSORY WAS UTILIZED FOR RECTAL STAPLING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY, WITH NO REPORTED INTRAOPERATIVE COMPLICATIONS, AND THE PATIENT WAS DISCHARGED ON THE 8TH POST-OPERATIVE DAY. SIX MONTHS AFTER THE OPERATION, THE PATIENT PRESENTED TO THE HOSPITAL WITH AIR AND FECAL MATTER LEAKING FROM THE VAGINA. CONTRAST IMAGING REVEALED A FISTULA BETWEEN THE POSTERIOR VAGINAL WALL AND THE STAPLE STUMP. THE SURGEON SUSPECTS THAT THE STAPLES AT THE END OF THE STAPLE LINE MAY HAVE CONTRIBUTED TO THE FISTULA'S FORMATION AS A B-SHAPED STAPLE PROTRUDED FROM THE TISSUE SURFACE AND HIT THE VAGINAL WALL. THERE WAS NO BLEEDING OBSERVED. THE PATIENT DID NOT REQUIRE FURTHER SURGICAL INTERVENTION AND REMAINS UNDER OBSERVATION, WITH AN IMPROVEMENT IN SYMPTOMS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15319 SUREFORM SUREFORM 45 RELOAD GREEN GDW INTUITIVE SURGICAL, INC 48345G N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Hospitalization DA VINCI INSTRUMENTS AND ACCESSORIES