DAVINCI XI
Report
- Report Number
- 2955842-2022-13082
- Event Type
- Malfunction
- Date Received
- July 27, 2022
- Date of Event
- June 21, 2022
- Report Date
- June 21, 2022
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874110898
- PMA / PMN Number
- K131861
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AN ISI FIELD SERVICE ENGINEER (FSE) HAS BEEN DISPATCHED TO INVESTIGATE THE REPORTED EVENT. THE FSE WAS ON SITE TO TROUBLESHOOT REPORTED ISSUE, AND WAS NOT ABLE TO DUPLICATE ISSUE. THE FSE REPLACED ERBE TO RESOLVE POTENTIAL INTERMITTENT ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE ERBE GENERATOR UNIT INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED POST ENGINEERING EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE VIDEO CLIP PROVIDED WAS CONDUCTED BY AN ISI SR. MANAGER, CDE. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "THIS OCCURRING BECAUSE THE MCS IS NOT IN CONTACT WITH TISSUE AND BEING AIR FIRED. HERE ARE SOME RELEVANT WARNINGS: WARNING: EXERCISE CAUTION WHEN WORKING WITH MONOPOLAR INSTRUMENTS CLOSE TO OTHER INSTRUMENTS. UNINTENDED ENERGY MAY BE DELIVERED FROM THE ACTIVE MONOPOLAR INSTRUMENT TO A SECOND INSTRUMENT. THIS COULD RESULT IN BURNS TO TISSUE IN CONTACT WITH ANY OF THE SECOND INSTRUMENT¿S METAL PARTS OR ITS CANNULA. TO EXERCISE CAUTION IN THESE SCENARIOS, THE MONOPOLAR TIP SHOULD BE CLOSER TO THE TISSUE THAN TO THE SECOND INSTRUMENT. WARNING: TO AVOID INADVERTENT ARCING FROM THE INSTRUMENT, DO NOT FIRE THE INSTRUMENT IF THE TIP IS NOT IN CONTACT WITH THE INTENDED TISSUE." THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: THE CUSTOMER EXPERIENCED REOCCURRING ENERGY ISSUES AFTER THE START OF THE PROCEDURE DUE TO THE INTEGRATED ELECTRO SURGICAL UNIT ERRORS. ADDITIONALLY, IT WAS ALLEGED THAT THE INSTRUMENT SMOKED. THE ALLEGATION COULD BE RELATED TO THE POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VIO DV INTEGRATED ELECTROSURGICAL UNIT (IESU) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE EVALUATION. THE REPORTED FAILURE (CUSTOMER REPORTED SMOKE COMING FROM BIPOLAR INSTRUMENT WHEN ACTIVATING MONOPOLAR ENERGY) COULD NOT BE REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. THE UNIT WILL BE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PYELOPLASTY SURGICAL PROCEDURE, THE CUSTOMER HAD A REOCCURRING ENERGY ISSUE; THAT WHEN MONOPOLAR ENERGY WAS BEING ACTIVATED, BIPOLAR ENERGY WAS ACTIVATED INSTEAD. CUSTOMER HAD A MARYLAND BIPOLAR ON UNIVERSAL SURGICAL MANIPULATOR 1 (USM1) AND A MONOPOLAR CURVED SCISSORS ON USM3. CUSTOMER SAID THEY AREN'T GETTING ANY ERROR MESSAGES AND THERE WERE NO ERRORS IN THE LOGS. WHEN THIS HAPPENS, THEY HAVE SEEN SMOKE COMING FROM THE BIPOLAR INSTRUMENT, BUT THEY WERE ACTIVATING THE MONOPOLAR ENERGY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2163404 | DAVINCI XI | VISION SIDE SYSTEM | NAY | INTUITIVE SURGICAL, INC | 381121-40 | N/A | 00886874110898 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |