DAVINCI XI
Report
- Report Number
- 2955842-2019-10201
- Event Type
- Death
- Date Received
- March 19, 2019
- Date of Event
- January 13, 2017
- Report Date
- January 25, 2017
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K131861
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS A2, A3, A4, A5, B3, B6, B7, G4, G7, H2, AND H10. ON (B)(6)2020 , INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT FROM THE SURGEON WHO PERFORMED THE DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE: THE SURGEON DID NOT PROVIDE THE OPERATIVE REPORT OF THE DA VINCI-ASSISTED SURGICAL PROCEDURE. HOWEVER, THE SURGEON PROVIDED THE FOLLOWING NARRATIVE OF THE PROCEDURE: ¿CREATES PNEUMO-PERITONEUM WITH A VERRES [SIC] NEEDLE UNDER LEFT ARCUS. PLACES 8MM ROBOTIC PORTS ON RIGHT ABDOMINAL SIDE, AND A 12MM ASSISTANT PORT ON RIGHT SIDE. THEN DOCKING THE ROBOT. WITH A HERNIA PORT IDENTIFYING A VENTRAL HERNIA ALONG THE MIDLINE THAT MEASURES 10 CM, AND A HERNIA POUCH THAT CONTAINS SMALL INTESTINE. USES A SCISSOR (MCS) TO TAKE DOWN THE INTESTINE STUCK IN HERNIA POUCH ¿ CAREFUL/DIFFICULT DISSECTION BECAUSE THE INTESTINE HAS CREATED ADHESIONS AND IS STUCK TO ABDOMINAL WALL. AFTER THE HERNIA HAS BEEN TAKEN DOWN ¿ A PREPERITONEAL SPACE IS CREATED WITH A FEW CM MARGINS TO THE SURROUNDING HERNIA EDGES. PLACES A SYMBOTEX MESH (CAN¿T REMEMBER THE SIZE) PREPERITONEAL WHICH IS ATTACHED BY A FEW SUTURES ALONG THE EDGE. CLOSES THE PERITONEUM AND GET A NICE CLOSURE/COVERING OF THE MESH. UNDOCK AND SUTURE THE FASCIA DEFECT FROM THE 12 MM PORT. PUTS SKIN STAPLERS TO CLOSE SKIN INCISIONS.¿ ADDITIONALLY, THE SURGEON COMMENTED: ¿THE PATIENT WAS NEVER SENT HOME AFTER THE PRIMARY SURGERY, HE WAS RE-OPERATED TWO DAYS AFTER THE FIRST SURGERY, DUE TO SUDDEN CLINICAL IMPAIRMENT. THE MESH WAS THEN REMOVED, AND A STAPLER WAS USED TO RESECT THE PROXIMAL AND DISTAL SIDE OF THE DAMAGED INTESTINE. BY THEN, THE PATIENT HAD ALDREADY [SIC] DEVELOPED A SEVERE SEPSIS, AND HIS CONDITION WAS NOT POSSIBLE TO IMPROVE, NOT EVEN THROUGH POST INTENSIVE CARE." FURTHERMORE, THE SURGEON NOTED: "THIS CASE IS REVISED AT THE DEPARTMENT OF SURGERY AND DEPARTMENT OF ANESTHESIOLOGY AT HALMSTAD HOSPITAL. THE PATIENT¿S RELATIVES WERE INFORMED VIA A LONG CALL BY THE PRIMARY-OPERATIVE SURGEON AND RE-OPERATIVE SURGEON. THE CASE WAS REVIEWED IN A ¿LEX MARIA-FASHION¿ BY THE HEALTH AND SOCIAL CARE INSPECTORATE, WHO DECIDED THAT THE ACTIONS TAKEN BY THE HOSPITAL WAS OF APPROVED STANDARD. AFTER THE SURGERY, THE INSPECTION SHOWED THAT A CORD/CABLE ON THE BIPOLAR ROBOTIC INSTRUMENT, THAT WAS USED ON THE PRIMARY SURGERY, HAD COME OFF. THIS COULD ALSO BE CONFIRMED WHEN WATCHING THE VIDEO RECORDING FROM THE SURGERY. IF THIS WAS A CONTRIBUTOR TO THE DAMAGE ON THE SMALL INTESTINE, WE CAN¿T KNOW FOR SURE. AFTER HAVING REVIEWED THE VIDEO SEVERAL TIMES, WE STILL CAN¿T SEE ANY OBVIOUS SIGNS THAT THIS COULD HAVE BEEN THE CAUSE OF DAMAGED INTESTINE. THEREFORE, WE ASSUMED THAT THE DAMAGED WAS PROBABLY CAUSED BY A [SIC] INACCURATE CUT WITH THE SCISSOR IN THE INTESTINE DURING RELEASE OF THE HERNIA POUCH.¿ IN REGARDS TO THE PATIENT¿S AUTOPSY, THE SURGEON NOTED THAT THE MAIN REASON FOR THE PATIENT¿S DEATH WAS ABDOMINAL SEPSIS CAUSED BY LEAKAGE FROM DAMAGED INTESTINE. A CONTRIBUTING CAUSE OF DEATH WAS GENERAL SEVERE ARTERIOSCLEROSIS. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. 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. ADDITIONALLY, ALL INSTRUMENTS USED IN THE CASE WERE USED IN SUBSEQUENT PROCEDURES, WITH THE EXCEPTION OF THE FOLLOWING: FENESTRATED BIPOLAR FORCEPS (PART #470205-13; LOT #N10160809-0040 AND SITE REVIEWS HAVE SHOWN THAT NO COMPLAINTS WERE FILED AGAINST THE INSTRUMENT. AS OF(B)(6)2020 , A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT CAME BACK TO THE HOSPITAL AND A BOWEL INJURY WAS FOUND. THE PATIENT REPORTEDLY DEVELOPED SEPSIS AND EXPIRED ON POST-OPERATIVE DAY #4. HOWEVER, AT THIS TIME, THE ROOT CAUSE OF THE OPERATIVE COMPLICATION LEADING TO THE PATIENT¿S DEMISE IS STILL UNKNOWN. THIS SUPPLEMENTAL REPORT, WITH ADDITIONAL INFORMATION COLLECTED, IS IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED (B)(6)2020.
REFER TO THE FOLLOWING FIELD FOR CORRECTED INFORMATION: D1, D2, AND D4 . REFER TO THE FOLLOWING FIELDS FOR UPDATED INFORMATION: D5, D7B, G3, G6, H2, AND H10. THIS REPORT IS BEING SUBMITTED TO PROVIDED CORRECTED PRODUCT-RELATED INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
BASED ON THE INFORMATION PROVIDED, ISI HAS NOT DETERMINED THE ROOT CAUSE FOR THE ALLEGED POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE PATIENT AND HIS SUBSEQUENT DEMISE. ISI HAS MADE ADDITIONAL ATTEMPTS TO CONTACT THE SURGEON TO OBTAIN FURTHER INFORMATION CONCERNING THE REPORTED EVENT. HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER COMPLETION OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PATIENT CAME BACK TO THE HOSPITAL AND A BOWEL INJURY WAS FOUND. THE PATIENT REPORTEDLY DEVELOPED SEPSIS AND EXPIRED ON AN UNSPECIFIED DATE. HOWEVER, AT THIS TIME, THE ROOT CAUSES OF THE OPERATIVE COMPLICATIONS AND PATIENT DEATH ARE UNKNOWN. NOTE: THIS INITIAL MDR (PATIENT IDENTIFIER # (B)(6)) IS ACTUALLY BEING SUBMITTED AS A FOLLOW-UP #1 (CORRECTION) MDR TO MFR REPORT #2955842-2017-00090 (PATIENT IDENTIFIER # (B)(6)) WHICH WAS SUBMITTED IN A COMPLAINT HANDLING DATABASE THAT IS NO LONGER AVAILABLE FOR MDR REPORT SUBMISSIONS. THE INITIAL MDR FOR MFR REPORT #2955842-2017-00090 WAS SUBMITTED ON TIME ON 02/13/2017 BUT WITH AN INCORRECT "TYPE OF REPORT" ENTRY OF "FOLLOW-UP #01." THE INITIAL MDR FOR MFR REPORT #2955842-2017-00090 SHOULD HAVE BEEN SUBMITTED WITH A CORRECT "TYPE OF REPORT" ENTRY OF "INITIAL" AND "30-DAY."
NOTE: REFER TO MFR REPORT #2955842-2017-00090 (PATIENT IDENTIFIER #(B)(6)) FOR THE ACTUAL INITIAL 30-DAY SUBMISSION OF THIS COMPLAINT - THIS IS A DUPLICATE. IT WAS REPORTED THAT AFTER COMPLETION OF A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT INITIALLY DID WELL POST-OPERATIVELY AND WENT HOME. A FEW DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN. THE PATIENT WAS EVALUATED AND A SMALL HOLE WAS FOUND IN THE PATIENT'S BOWEL. THE PATIENT REPORTEDLY EXPIRED ON AN UNSPECIFIED DATE. ON 01/30/2017, INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION REGARDING THE REPORTED EVENT: THE PATIENT SUSTAINED UNSPECIFIED "PERIOPERATIVE DAMAGE" TO THE SMALL INTESTINE AND DEVELOPED SEPSIS. THE SURGEON INDICATED THAT AN "AUTOPSY SHOWED THAT THE PATIENT HAD SEVERE VASCULAR DISEASE, WHICH MEANT THAT HE COULD NOT HANDLE SUCH A COMPLICATION." NO OTHER CLINICAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226164 | DAVINCI XI | PATIENT SIDE CART, 4-ARM | NAY | INTUITIVE SURGICAL, INC | 380652-31 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Death| H| L| R | DA VINCI INSTRUMENTS AND ACCESSORIES |