DA VINCI SP
Report
- Report Number
- 2955842-2022-13792
- Event Type
- Injury
- Date Received
- August 31, 2022
- Date of Event
- June 8, 2022
- Report Date
- August 1, 2022
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874114605
- PMA / PMN Number
- K182371
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S POST-OPERATIVE COMPLICATION IS UNKNOWN. ISI HAS ATTEMPTED TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT/INCIDENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE AT THIS TIME. THE SYSTEM WAS NOT CONNECTED TO THE NETWORK. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER A COMPLETED SP COLORECTAL IDE STUDY LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) PROCEDURE, THE PATIENT DEVELOPED BILATERAL EDEMA OF THE LOWER EXTREMITIES, GIDDINESS, ANOREXIA WITH ACUTE RENAL FAILURE. AT THIS TIME, THE ROOT CAUSE OF THE ALLEGED ISSUE IS UNKNOWN.
ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: B6, B7, G3, G6, H2, AND H10. ON 12-SEP-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT: ON 16-AUG-2022, THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT (ED) FOR ANOREXIA SINCE HER BARIUM ENEMA ON 21-JUL-2022. SHE HAD BEEN TAKING LASIX AND REPORTED DIZZINESS AND WEAKNESS. LAB TESTS DEMONSTRATED HYPERKALEMIA AND HYPONATREMIA AND THE PATIENT WAS ADMITTED ON 16-AUG-2022 AFTER A NEPHROLOGY CONSULT FOR ACUTE RENAL FAILURE (ARF). SHE WAS TREATED WITH INTRAVENOUS FLUIDS, MIDODRINE AND ORAL SUPPLEMENTS FOR THE ARF AND DISCHARGED ON 24-AUG-2022 AFTER IMPROVEMENT OF HER SYMPTOMS WAS OBSERVED. RELEVANT LAB TESTS: SODIUM INCREASED FROM 119 MEQ/L ON 08/16, TO 140 MEQ/L AT THE TIME OF DISCHARGE. POTASSIUM DECREASED FROM 5.4 MEQ/L ON 08/16, TO 3.4 MEQ/L AT THE TIME OF DISCHARGE. CREATININE ALSO DECREASED FROM 2.20 MG/DL ON 08/18, TO 0.90 MG/DL AT THE TIME OF DISCHARGE. RENAL ULTRASOUND ON 08/17: NO SUSPICIOUS RENAL SONOGRAPHIC ABNORMALITY. BARIUM ENEMA FINDINGS: COLON WAS NORMALLY DISTENSIBLE. SCATTERED DIVERTICULA WERE SEEN. NO FIXED OR ANNULAR MASS WAS NOTED. CONTRAST WAS SEEN FLOWING INTO THE RIGHT LOWER QUADRANT COLOSTOMY. IMPRESSION: UNREMARKABLE GASTROGRAFIN ENEMA.
ON 12-OCT-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT: THE PATIENT EXPERIENCED A NEW ONSET OF ACUTE RENAL FAILURE (ARF) WAS (B)(6) 2022. THE PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL WITH ARF. SHE PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO GENERALIZED WEAKNESS. THE PATIENT HAS BEEN HAVING DECREASED ORAL INTAKE FOR THE PAST COUPLE OF MONTHS FOR WHICH SHE WAS ADMITTED AND DISCHARGED. THE PATIENT REPORTED DRINKING LIQUIDS ONLY WITH NO SOLID FOOD INTAKE HENCE HAD WEIGHT LOSS OF 60 POUNDS WITHIN 3 WEEKS. SHE WAS RECENTLY SEEN IN THE CARDIAC CLINIC FOR CARDIAC CLEARANCE BEFORE COLON SURGERY. HER STRESS EKG WAS NEGATIVE FOR ISCHEMIA. SHE DENIED CHILLS, FEVER, HEADACHE, DIARRHEA, CONSTIPATION, SHORTNESS OF BREATH OR CHEST PAIN. SHE WAS ON IV FLUIDS. NUTRITION RECOMMENDED A HEART HEALTHY DIET AS MEDICALLY APPROPRIATE AND ORAL INTAKE WAS ENCOURAGED. IF HYPERGLYCEMIA PERSISTED, A 2000 KCAL CARBOHYDRATE CONTROLLED DIET RESTRICTION WAS RECOMMENDED.
ADDITIONAL INFORMATION WAS OBTAINED AS BELOW: THE PATIENT WAS PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2023 WITH WORSENING KIDNEY FUNCTION. THE PATIENT WAS DIAGNOSED WITH CHRONIC KIDNEY DISEASE (STAGE V) AND WAS STARTED ON HEMODIALYSIS. SHE WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2023 TO A REHABILITATION FACILITY WITH DIALYSIS ACCESS. THE PATIENT WAS AGAIN PRESENTED TO THE ER ON (B)(6) 2024 FOR A HYPOTENSIVE EPISODE POST HEMODIALYSIS. THE PATIENT WAS FOUND TO BE IN ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE AND WAS STARTED ON AMIODARONE AND APIXABAN. THE PATIENT WAS CONTINUED WITH MIDODRINE AND FLUDROCORTISONE AND WAS LATER DISCHARGED TO HOME ON (B)(6) 2024 WITH A COURSE OF CEPHALEXIN FOR POSSIBLE URINARY TRACT INFECTION.
IT WAS REPORTED THAT AFTER A COMPLETED SINGLE PORT (SP) COLORECTAL IDE STUDY LOW ANTERIOR RESECTION (LAR) WITH TOTAL MESORECTAL EXCISION (TME) PROCEDURE ON (B)(6) 2022, THE PATIENT DEVELOPED BILATERAL EDEMA OF THE LOWER EXTREMITIES AND GIDDINESS. THE LEG SWELLING AND GIDDINESS WERE NOTED ON (B)(6) 2022, DURING A FOLLOW-UP VISIT WITH HER PRIMARY CARE PHYSICIAN (PCP) AND THE PATIENT'S ORAL LOSARTAN WAS PLACED ON HOLD BY HER PCP, AND SHE WAS ADVISED TO FOLLOW-UP IN 2-3 WEEKS¿ TIME. ON (B)(6) 2022, THE PATIENT WENT TO THE ER FOR GENERALIZED WEAKNESS AND DIZZINESS FOR A FEW WEEKS. THE DIZZINESS WAS WORSE UPON STANDING UP. SHE ALSO HAD LOSS OF APPETITE. THERE WAS NO PAIN. SHE STATED THAT THE WEAKNESS AND LOSS OF APPETITE STARTED EVER SINCE SHE HAD A BARIUM ENEMA ON (B)(6) 2022. A BLOOD TEST SHOWED ACUTE RENAL FAILURE WITH CREATININE 2.2, BUN 106, SODIUM 119, POTASSIUM 5.4. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SITE. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2634213 | DA VINCI SP | PATIENT SIDE CART | NAY | INTUITIVE SURGICAL, INC | 380601-40 | N/A | 00886874114605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | DA VINCI INSTRUMENTS AND ACCESSORIES |