ENDOWRIST
Report
- Report Number
- 2955842-2024-20881
- Event Type
- Injury
- Date Received
- October 22, 2024
- Date of Event
- September 24, 2024
- Report Date
- September 24, 2024
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874119808
- PMA / PMN Number
- K214095
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.
ADDITIONAL INFORMATION: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT PARTIAL NEPHRECTOMY, THE PROCEDURE WAS CONVERTED TO OPEN DUE TO UNCONTROLLABLE BLEEDING AND THE PATIENT'S DIFFICULT ACCESS TO THE "RETRO VEIN." AFTER DISSECTING THE RENAL PEDICLE TO SECURE THE ARTERIES, THE LEFT POLAR ARTERY WAS SEVERED FLUSH WITH THE AORTA. ONCE THE INJURY OCCURRED, THE ARTERY WAS CLAMPED AND THE OTHER INSTRUMENTS WERE REMOVED SO THE SYSTEM COULD BE UNDOCKED, AND THE INCISION WAS MODIFIED TO CONVERT THE PROCEDURE TO OPEN. ONCE CONVERTED, THE AREA WAS MARKED, AND THE SURGEON DISSECTED AROUND THE BIPOLAR INSTRUMENT THAT BEING USED AS A CLAMP. A HEM-O-LOC CLIP WAS PLACED FLUSH WITH THE AORTA AND THE BIPOLAR INSTRUMENT WAS REMOVED MANUALLY. TO COMPLETE THE REPAIR THE VASCULAR SURGEON PLACED TWO "X- STITCHES" ON THE AORTIC WOUND. THE PATIENT LOST 800 CC OF BLOOD DURING THE PROCEDURE, 650 CC OF THAT WAS FROM THE ARTERIAL WOUND, AND THE PATIENT RECEIVED 2 UNITS OF BLOOD. WHEN ASKED WHAT ABOUT THE PATIENT'S ANATOMY PROMPTED THE CONVERSION, THE SURGEON SAID THE UNCONTROLLABLE BLEEDING AND THE PATIENT'S ACCESS TO THE "RETRO VEIN" WAS DIFFICULT. THERE WAS NOTHING IN THE PATIENT'S PREOPERATIVE ASSESSMENT OR MEDICAL HISTORY CAUSING THE SURGEON TO ANTICIPATE THE CONVERSION. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS PAST THE STANDARD FOR THE PROCEDURE (6 AS OPPOSED TO 2), BUT THE SURGEON IS NOT CONCERNED ABOUT LONG TERM COMPLICATIONS. DEVICE EVALUATION: THE PRODUCT WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) AND FAILURE ANALYSIS (FA) CONFIRMED BUT DID NOT REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT UNDERWENT INTERNAL AND EXTERNAL INSPECTION, NO ISSUES WERE DETECTED AND FA COULD NOT VERIFY THE CUSTOMER REPORTED EVENT. THE INSTRUMENT WAS TESTED ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS, THE GRIP TIPS OPENED AND CLOSED PROPERLY, AND THE INSTRUMENT PASSED ENERGY DELIVERY TESTING IN VARIOUS GRIP ORIENTATIONS. THE INSTRUMENT ALSO PASSED THE ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL, AND NO PRODUCT ISSUE WAS FOUND. THE ERROR LOGS INDICATE THE PRESENCE OF AN ERROR CODE CONFIRMING THAT THE INSTRUMENT RELEASE KIT WAS UTILIZED TO REMOVE THE INSTRUMENT FROM THE SYSTEM.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY DUE TO PATIENT ANATOMY AND SURGEON PREFERENCE. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS USED AS A CLAMP ON AN ARTERY DURING THE CONVERSION. THE INSTRUMENT WAS SUBSEQUENTLY MANUALLY RELEASED. THOUGH IT WAS STATED PATIENT ANATOMY AND SURGEON PREFERENCE WAS THE REASON FOR THE CONVERSION, IT IS UNCLEAR WHAT OCCURRED THAT CREATED A NEED FOR THE INSTRUMENT TO BE USED AS A CLAMP ON THE ARTERY.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293842 | ENDOWRIST | FENESTRATED BIPOLAR FORCEPS | NAY | INTUITIVE SURGICAL, INC | 471205-17 | K14240327 0078 | 00886874119808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Male | Required Intervention| H | DA VINCI INSTRUMENTS AND ACCESSORIES |