BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFORM

    MDR report key: 10335690 · Received July 28, 2020

    Report

    Report Number
    2955842-2020-10690
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 1, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    GDW
    PMA / PMN Number
    K173721
    Removal / Correction Number
    ISIFA2022-02-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON A RE-EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT HAS BEEN RECLASSIFIED AS AN ADVERSE EVENT AND PRODUCT PROBLEM RATHER THAN JUST AN ADVERSE EVENT AS PREVIOUSLY REPORTED DUE TO THE REPORT OF POSTOPERATIVE BLEEDING, WHICH COULD POTENTIALLY BE RELATED TO A PRODUCT PROBLEM. CORRECTED INFORMATION CAN BE FOUND THE FOLLOWING FIELDS: B1, ANNEX E, ANNEX F, ANNEX A AND ANNEX G B1 UPDATED FROM "ADVERSE EVENT" TO "ADVERSE EVENT AND PRODUCT PROBLEM" ANNEX E UPDATED TO INCLUDE E0506 DUE TO THE REPORT OF ¿BLEEDING¿ ANNEX F UPDATED TO INCLUDE F23 DUE TO THE REPORT OF ¿PATIENT IMMEDIATELY UNDERWENT A LAPAROSCOPIC SURGICAL PROCEDURE.¿ ANNEX A UPDATED TO INCLUDE A050704 DUE TO THE REPORT OF ¿STAPLE LINE THAT WAS BLEEDING.¿ ANNEX G UPDATED TO INCLUDE G0405214 AS COMPLAINT IS RELATED TO THE STAPLE.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G4, G7, H2, AND H10. CORRECTED INFORMATION CAN BE FOUND IN THE FOLLOWING FIELD: G5. FIELD G5 - 510K SHOULD HAVE BEEN POPULATED WITH K173721.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION. NONE OF THE SUREFORM 60 RELOADS USED DURING THE CASE ARE AVAILABLE FOR RETURN TO ISI FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI HAS REVIEWED THE SITE¿S SYSTEM LOGS WITH A PROCEDURE DATE OF (B)(6) 2020. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. LOG REVIEW INDICATED STAPLER PN 480460-09, LOT L90200206-0017 FIRED 6 BLUE SUREFORM RELOADS. ALL FIRINGS COMPLETED WITH NO PAUSES PER LOGS, AND NO INCOMPLETE CLAMPS ON ANY INSTALL. AS OF 25-JUL-2020, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. IMAGE/VIDEO REVIEW - NO IMAGES OR VIDEOS WERE SHARED FOR THE EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THE PATIENT EXPERIENCED A STAPLE LINE LEAK. AS A RESULT, THE PATIENT UNDERWENT A SECONDARY TRADITIONAL LAPAROSCOPIC SURGICAL PROCEDURE TO RESOLVE THE STAPLE LINE LEAK. ALTHOUGH IT WAS CONFIRMED THAT THE SITE DID NOT ALLEGE ANY MALFUNCTION OF A DAVINCI PRODUCT, THE CAUSE OF THE POST-OPERATIVE COMPLICATION IS UNKNOWN AT THIS TIME. THE STAPLE LINE FROM THE INITIAL ROBOTIC PROCEDURE WAS REPORTEDLY INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITHIN TWO HOURS AFTER UNDERGOING A DA VINCI-ASSISTED GASTRECTOMY PROCEDURE, THE PATIENT WAS FOUND TO HAVE A POST-OPERATIVE STAPLE LINE LEAK. AS A RESULT, THE PATIENT ALLEGEDLY UNDERWENT A SECOND PROCEDURE TO REPAIR THE LEAK. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE STAPLE LINE LEAK IS UNKNOWN. ON 24-JUL-2020, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI CLINICAL SALES ASSOCIATE (CSA) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT WAS A (B)(6)-YEAR-OLD, HISPANIC FEMALE, AS PER THE SURGEON WITH "NOTHING OUT OF THE NORM MEDICAL HISTORY." IT WAS REPORTED THAT ON (B)(6) 2020 (THE FIRST PROCEDURE OF THE DAY), THE PATIENT UNDERWENT A SLEEVE GASTRECTOMY PROCEDURE. THE SUREFORM 60 STAPLER INSTRUMENT WAS USED DURING THE PROCEDURE WITH BLUE SUREFORM 60 RELOADS. THERE WERE NO STAPLING RELATED ISSUES OBSERVED DURING THE DA VINCI-ASSISTED SURGICAL PROCEDURE. ALSO, THERE WERE NO REPORTED INTRA-OPERATIVE COMPLICATIONS. IT WAS CONFIRMED THAT THERE WERE NO CLAMPING ISSUES, NO SYSTEM GENERATED ERROR, NO PAUSES DURING CLAMPING, NO TISSUE TENSION OR BUNCHING, AND NO BUTTRESS MATERIAL WAS USED. HOWEVER, WITHIN TWO HOURS OF THE PROCEDURE, THE PATIENT WAS BLEEDING, AND THE BLOOD COUNT DROPPED. AS A RESULT, THE PATIENT IMMEDIATELY UNDERWENT A LAPAROSCOPIC SURGICAL PROCEDURE. THE SURGEON IDENTIFIED AN INTACT STAPLE LINE THAT WAS BLEEDING. IT WAS REPORTED TO BE MOST LIKELY THE LAST STAPLE LINE OF THE INITIAL SLEEVE GASTRECTOMY PROCEDURE. THE SURGEON SUCTIONED BLOOD FROM THE BLEEDING STAPLE LINE, THEN APPLIED SURGICEL, A HEMOSTATIC GLUE, AND HEMOCLIPS TO ADDRESS THE BLEEDING. THE ESTIMATED BLOOD LOSS WAS 1200ML, AND THE PATIENT HAD TWO UNITS OF BLOOD TRANSFUSED TO ADDRESS THE BLOOD LOSS. IT WAS CONFIRMED THAT THERE WAS NO ALLEGATION THAT AN ISI INSTRUMENT, ACCESSORY, OR SYSTEM MALFUNCTIONED. THE CSA CONFIRMED THAT THE SUREFORM STAPLER INSTRUMENT AND ALL THE RELOADS USED DURING THE PROCEDURE WERE DISCARDED SINCE THERE WERE NO STAPLING RELATED ISSUES DURING THE INITIAL PROCEDURE. THERE ARE NO VIDEO RECORDINGS OR PHOTOGRAPHIC IMAGES OF EITHER THE INITIAL ROBOTIC GASTRECTOMY OR THE SECOND LAPAROSCOPIC PROCEDURE, AVAILABLE FOR REVIEW. THE PATIENT IS REPORTED TO BE RECOVERING WELL. THE CAUSE OF THE PATIENT'S POST-OPERATIVE COMPLICATION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797299 SUREFORM STAPLER 60 RELOAD BLUE GDW INTUITIVE SURGICAL, INC 48360B N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES.