DAVINCI XI
Report
- Report Number
- 2955842-2020-10272
- Event Type
- Injury
- Date Received
- April 3, 2020
- Date of Event
- February 6, 2020
- Report Date
- May 11, 2020
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K131861
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SE
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS G4, G7, H2, AND H10. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS SENT TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THE UNIT'S ERROR LOG WAS EXAMINED. A NEUTRAL PAD ERROR (M-0B-316) WAS FOUND TO HAVE OCCURRED ON SEVERAL DATES. HOWEVER, AS PART OF THE UNIT'S SAFETY FEATURES, THIS CODE TYPICALLY OCCURS WHEN A CONTACT RESISTANCE ABOVE 120 OHM IS DETECTED (NEUTRAL PAD NOT APPLIED TO THE PATIENT). FURTHER EVALUATION OF THE UNIT FOUND IT TO BE FUNCTIONING PROPERLY AND WITHIN SPECIFICATIONS OF THE DEVICE. THEREFORE, NO TROUBLE WAS FOUND THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. ON (B)(6)2020 , INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING CONCLUSION FROM THE MANUFACTURER REGARDING THIS EVENT: THE CUSTOMER REPORTED OPERATIVE COMPLICATION DID NOT RESULT FROM A DEFECTIVE DEVICE. DUE TO MISSING DETAILED INFORMATION ABOUT THE INJURY AND THE FURTHER COURSE OF THE DISEASE A MORE PRECISE ANALYSIS OF THE CAUSE WAS NOT POSSIBLE. THE SAFETY INSTRUCTIONS OF THE INSTRUCTIONS FOR USE (IFU) REFER TO THE IRRITATION OF MUSCLES AND NERVES DUE TO LOW-FREQUENCY CURRENTS AND DIRECT CURRENT (DC) COMPONENTS. THIS EFFECT IS UNABLE TO BE PHYSICALLY AVOIDED AND CAN LEAD TO MUSCLE TWITCHING AND PAIN PERCEPTION. PER THE MANUFACTURER, THIS INCIDENT WOULD NOT BE REPORTABLE AS THERE WAS NO SERIOUS INJURY AND THE ERBE IESU WAS CONFIRMED TO BE WITHIN DEVICE SPECIFICATIONS. REVIEW OF THE MANUFACTURER'S IFU WAS CONDUCTED. USERS ARE INSTRUCTED TO SET THE EFFECT AS LOW AS POSSIBLE RELATIVE TO THE REQUIRED SURGICAL EFFECT. INCORRECT APPLICATION OF THE NEUTRAL ELECTRODE IS STATED TO HAVE A RISK OF BURNS TO THE PATIENT. THE FOLLOWING STATEMENTS ARE INCLUDED IN THE IFU REGARDING PLACEMENT OF THE NEUTRAL PAD: "APPLY THE ENTIRE CONTACT SURFACE OF THE NEUTRAL ELECTRODE TO A MUSCULAR PART OF THE BODY WITH GOOD BLOOD CIRCULATION. APPLY THE NEUTRAL ELECTRODE AS CLOSE AS POSSIBLE TO THE SURGICAL SITE. CHECK THE NEUTRAL ELECTRODE REGULARLY FOR GOOD CONTACT WITH THE PATIENT'S SKIN. CHECK THE NEUTRAL ELECTRODE ESPECIALLY WHEN THE PATIENT HAS BEEN REPOSITIONED AND AFTER SURGICAL STEPS WHERE THE DEVICE WAS ACTIVATED FREQUENTLY AND FOR A LONG TIME." BASED ON AVAILABLE INFORMATION AND DEVICE EVALUATION, THE ROOT CAUSE WAS UNABLE TO BE CONFIRMED; HOWEVER, THE MOST LIKELY CAUSE WAS DETERMINED TO BE INCORRECT PLACEMENT/USE OF THE NEUTRAL PAD.
ADDITIONAL INFORMATION CAN BE FOUND IN SECTIONS A2, A3, A4, G4, G7, H2, H3, H6, AND H10. DEVICE EVALUATION INFORMATION CAN BE FOUND IN SECTIONS H6 AND H10. 67 - THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WAS RETURNED FOR FAILURE ANALYSIS BUT THE REPORTED FAILURE OF A NEUTRAL PAD ISSUE COULD NOT BE REPRODUCED. THE CUSTOMER REPORTED A POSSIBLE INJURY TO THE PATIENT (NUMBNESS AND LOSS OF SENSITIVITY) WHERE THE NEUTRAL PAD WAS PLACED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS. NO ISSUES OCCURRED. THE UNIT PASSED A TECHNICAL SAFETY CHECK. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE SITE TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE CURRENT INFORMATION PROVIDED, THIS COMPLAINT WILL REMAIN REPORTABLE DUE TO THE FOLLOWING CONCLUSION: A PATIENT INJURY ALLEGEDLY OCCURRED IN RELATION TO THE USE OF AN ERBE GENERATOR. IT WAS NOTED THAT THE PATIENT EXPERIENCED PAIN AND LOSS OF SENSITIVITY WHERE A NEUTRAL ELECTRODE WAS PLACED. AT THIS TIME, THE CAUSE AND SEVERITY OF THE ALLEGED OPERATIVE COMPLICATIONS IS STILL UNKNOWN. IT IS ALSO UNCLEAR IF THE PAIN AND LOSS OF SENSITIVITY WERE TEMPORARY/TRANSIENT OR CHRONIC/PERMANENT.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION IS UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAS MADE SEVERAL ATTEMPTS TO FOLLOW UP WITH THE SITE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT. ON 13-MAR-2020, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO VERIFY ANY FAULT WITH THE ERBE GENERATOR. HOWEVER, THE FSE REPLACED THE ERBE GENERATOR AS A PRECAUTION. THE FSE TESTED THE SYSTEM AND VERIFIED THAT IT WAS READY FOR USE. ISI HAS RECEIVED THE ERBE GENERATOR. HOWEVER, AS OF THE DATE OF THIS REPORT, THE EVALUATION OF THE ERBE GENERATOR HAS NOT BEEN COMPLETED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. NO RELATED SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE. ISI HAS ALSO REVIEWED THE SITE'S COMPLAINT HISTORY AND NO RELATED COMPLAINTS HAVE BEEN IDENTIFIED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A PATIENT INJURY OCCURRED IN RELATION TO THE USE OF AN ERBE GENERATOR. IT WAS NOTED THAT THE PATIENT EXPERIENCED PAIN AND LOSS OF SENSITIVITY WHERE A NEUTRAL ELECTRODE WAS PLACED. AT THIS TIME, THE CAUSE AND SEVERITY OF THE ALLEGED OPERATIVE COMPLICATIONS ARE UNKNOWN. IT IS ALSO UNCLEAR IF THE PAIN AND LOSS OF SENSITIVITY WERE TEMPORARY/ TRANSIENT OR CHRONIC/ PERMANENT. FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION WAS EITHER UNKNOWN OR UNAVAILABLE. THE EXPIRATION DATE IS NOT APPLICABLE. NOT APPLICABLE BECAUSE THE PRODUCT IS NOT IMPLANTABLE.
IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, A PATIENT INJURY ALLEGEDLY OCCURRED INVOLVING THE USE OF AN ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU). PER THE INITIAL REPORTER, THE PATIENT EXPERIENCED PAIN AND LOSS OF SENSITIVITY ON THEIR LEG WHERE A NEUTRAL ELECTRODE HAD BEEN PLACED. THE SITE HAS NOT DETERMINED THE CAUSE OF THE REPORTED OPERATIVE COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386126 | DAVINCI XI | VISION SIDE SYSTEM | NAY | INTUITIVE SURGICAL, INC | 951300-02 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Other | DA VINCI INSTRUMENTS AND ACCESSORIES |