DA VINCI

Additional Manufacturer Narrative

INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE AUTHOR CONFIRMS THAT NO DEVICE MALFUNCTIONS OCCURRED DURING THE PROCEDURES, AND NO RE INTERVENTIONS WERE REQUIRED DUE TO PRODUCT-RELATED ISSUES OR INJURIES. ADDITIONALLY, THEY STATED THAT PATIENT INFORMATION CANNOT BE RELEASED.

Description of Event or Problem

REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

Additional Manufacturer Narrative

THIS COMPLAINT REFLECTS ADVERSE EVENT-ONLY DATA FROM A LITERATURE ARTICLE. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. ADDITIONALLY, THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. CITATIONS: EFFECT OF ROBOTIC VERSUS OPEN PANCREATICODUODENECTOMY ON POSTOPERATIVE LENGTH OF HOSPITAL STAY AND COMPLICATIONS FOR PANCREATIC HEAD OR PERIAMPULLARY TUMOURS: A MULTICENTRE, OPEN-LABEL RANDOMISED CONTROLLED TRIAL. HTTPS://DOI.ORG/10.1016/S2468-1253(24)00005-0. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. DUE TO THE LACK OF SPECIFIC INFORMATION ON THE EXACT DEMOGRAPHICS OF THE PATIENTS, THE MEDIAN/MEAN AGE AND THE GENDER REPRESENTING THE MAJORITY OF THE PATIENT POPULATION HAVE BEEN USED. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE. DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER HAS BEEN USED. DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE EVENT DATE ASSOCIATED WITH THE ADVERSE EVENT, AN ALTERNATE DATE, PUBLISHED DATE HAS BEEN USED. LINK OF THE ARTICLE CITATION, DOI: HTTPS://DOI.ORG/10.1016/S2468-1253(24)00005-0.

Description of Event or Problem

IN A RANDOMIZED CONTROLLED TRIAL BASED ON DA VINCI-ASSISTED ROBOTIC PANCREATICODUODENECTOMY (RPD), THE AUTHORS COMPARED THE SHORT-TERM POSTOPERATIVE OUTCOMES OF RPD WITH THOSE OF OPEN PANCREATICODUODENECTOMY (OPD). THE TRIAL, CONDUCTED BETWEEN MARCH 5 AND DECEMBER 20, 2022, INCLUDED 164 PATIENTS RANDOMLY ASSIGNED TO EITHER THE RPD OR OPD GROUP. IN THE RPD GROUP, 22% OF PATIENTS EXPERIENCED MAJOR POSTOPERATIVE COMPLICATIONS (GRADE 3 OR HIGHER), WITH 14% DEVELOPING GRADE B OR C POSTOPERATIVE PANCREATIC FISTULA (POPF). INTRAOPERATIVE ADVERSE EVENTS OF GRADE 2 OR HIGHER OCCURRED IN 17% OF RPD CASES, AND 4% OF PROCEDURES REQUIRED CONVERSION TO OPEN SURGERY. BLOOD TRANSFUSIONS WERE NEEDED IN 3% OF CASES, AND OTHER COMPLICATIONS SUCH AS BILE LEAKAGE, HEMORRHAGE, DELAYED GASTRIC EMPTYING, AND INTRA-ABDOMINAL INFECTIONS WERE OBSERVED BUT DID NOT SIGNIFICANTLY DIFFER FROM THE OPD GROUP. REOPERATIONS WERE NECESSARY IN 3% OF RPD CASES, ALL DUE TO HEMORRHAGE, AND 7% OF PATIENTS REQUIRED READMISSION WITHIN 90 DAYS, PRIMARILY FOR ISSUES LIKE INTRA-ABDOMINAL HEMORRHAGE, VOMITING, ELECTROLYTE DISTURBANCES, AND FEVER. PATIENTS IN THE RPD GROUP HAD A SHORTER TOTAL POSTOPERATIVE STAY AND QUICKER INITIATION OF ADJUVANT THERAPY. NO SPECIFIC MALFUNCTIONS OF THE INTUITIVE DEVICE OR ACCESSORIES WERE REPORTED. THE STUDY HAD SEVERAL LIMITATIONS, INCLUDING THE OPEN-LABEL DESIGN, WHICH WAS CHOSEN DUE TO THE IMPRACTICALITY OF MASKING THE TREATMENTS. EFFORTS WERE MADE TO MINIMIZE BIAS, INCLUDING MASKING DATA COLLECTORS AND ANALYSTS, STANDARDIZING PERIOPERATIVE MANAGEMENT, AND APPLYING STRICT DISCHARGE CRITERIA. THE TRIAL'S GENERALIZABILITY IS LIMITED DUE TO ITS CONDUCT IN HIGH-VOLUME CENTERS BY EXPERIENCED SURGEONS AND THE INCLUSION OF A LARGER PROPORTION OF NON-OBESE PATIENTS. ADDITIONALLY, WHILE RPD SHOWED BENEFITS IN REDUCING HOSPITAL STAY, THE OVERALL CLINICAL BENEFIT REMAINS UNCLEAR, ESPECIALLY CONSIDERING THE EXTRA COSTS AND PATIENT PERCEPTIONS OF QUALITY OF LIFE AND RECOVERY AFTER DISCHARGE.