ENDOWRIST
Report
- Report Number
- 2955842-2019-10868
- Event Type
- Malfunction
- Date Received
- November 4, 2019
- Date of Event
- July 30, 2019
- Report Date
- December 19, 2019
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K131861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- 003
Narratives
INITIAL MDR H10/H11 SUBMITTED ON(B)(6)2019 : 67 - INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE PERMANENT CAUTERY SPATULA INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE PERMANENT CAUTERY HOOK/ PERMANENT CAUTERY SPATULA INSTRUMENT ARCED, SMOKED, OR HAD CONDUCTOR WIRE DAMAGE WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING OR MISUSE. FOLLOW-UP MDR #1 H10/H11 SUBMITTED ON (B)(6)2019 : 61 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED ISSUE. THE INSTRUMENT WAS FOUND TO HAVE DAMAGE OF THE CONDUCTOR WIRE¿S INSULATION. THIS FAILURE IS COMMONLY CAUSED BY MISHANDLING/MISUSE, SUCH AS COLLISION OF THE INSTRUMENT WITH A SHARP OBJECT. THE EAR OF THE DISTAL CLEVIS WAS CUT FOR INSPECTION. THERE WAS NO WELD DAMAGE FOUND. ADDITIONAL INFORMATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY, LIKELY CAUSED BY THE INSULATION DAMAGE. THE INSTRUMENT WAS ALSO FOUND TO HAVE INDENTATIONS ON THE EDGE OF THE DISTAL IDLER PULLEYS. THE FAILURE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE, SUCH AS INSTRUMENT COLLISIONS OR IMPACT FROM AN EXTERNAL OBJECT. BASED ON THE DEVICE EVALUATION RESULTS, THIS MDR REPORT IS BEING RETRACTED SINCE THE FAILURE MODE WAS FOUND TO BE DUE TO USER MISUSE/MISHANDLING AND NOT DUE TO A MALFUNCTION OF THE INSTRUMENT. NEW ADDITIONAL/CORRECTED INFORMATION: ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: B1, D4, G4, G7, H2, H5, H6, H8 AND H10. 4307 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY SPATULA INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE REPORTED ISSUE OF ¿SIDE-FIRING¿ OR ARCING. THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS FOUND TO HAVE DAMAGE TO THE CONDUCTOR WIRE¿S INSULATION. AS A RESULT OF THIS INSULATION DAMAGE, THE MONOPOLAR YAW PULLEY WAS FOUND TO HAVE INCURRED THERMAL DAMAGE. THE WELD WAS INSPECTED AND NO DAMAGE WAS FOUND. 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. A LOG REVIEW CONFIRMED THAT THE REPORTED ISSUE OCCURRED ON THE INSTRUMENT¿S FIRST USAGE ON SK0577 ON(B)(6)2019 . NO IMAGE OR VIDEO INVESTIGATION WAS PERFORMED AS NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BECAUSE DAMAGE TO THE CONDUCTOR WIRE OF THE INSTRUMENT COULD LEAD TO UNINTENDED 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. B1: PRODUCT PROBLEM WAS SELECTED AS THERE IS EVIDENCE THAT THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. D4: THE PRODUCT CATALOG NUMBER HAS BEEN POPULATED AS IT WAS BLANK IN THE PREVIOUS REPORTS. G4 WAS UPDATED TO THE DATE THAT INTUITIVE SURGICAL, INC. (ISI) COMPLETED FAILURE ANALYSIS INVESTIGATIONS. H5: POPULATED AS "NO" AS THIS INSTRUMENT IS NOT A SINGLE-USE INSTRUMENT. H6: RESULT CODES AND CONCLUSION CODES UPDATED BASED ON THE FAILURE ANALYSIS RESULTS DETAILED ABOVE. H8: POPULATED AS "INITIAL USE OF DEVICE" AS THE INVESTIGATION REVEALED THAT THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S FIRST USAGE. BLANK MDR FIELDS: FOLLOW-UP WAS ATTEMPTED, BUT THE PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN OR UNAVAILABLE. THE SECTIONS OF D4 THAT ARE NOT APPLICABLE TO THIS PRODUCT ARE BLANK. DEVICE EXPIRATION DATE FOR SECTION D4 WAS LEFT BLANK AS THIS INSTRUMENT HAS (B)(4) USAGES ALLOTTED TO IT, WHICH ARE TRACKED BY THE DA VINCI SURGICAL SYSTEM. THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S FIRST USAGE AND, THEREFORE, HAD NOT EXPIRED. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. THIS REPORT HAS BEEN GENERATED IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED (B)(6)2020
INTUITIVE SURGICAL, INC. (ISI) FOLLOWED-UP WITH THE HOSPITAL AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE HOSPITAL IS UNABLE TO RELEASE PATIENT INFORMATION; HOWEVER, THEY WERE ABLE TO CONFIRM THAT THE ¿PATIENT WAS NOT HARMED IN ANY WAY AT ALL.¿ THE INSTRUMENTS AND CANNULAS WERE INSPECTED PRIOR TO THE PROCEDURE. NO FURTHER INFORMATION WAS AVAILABLE.
61 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED ISSUE. THE INSTRUMENT WAS FOUND TO HAVE DAMAGE OF THE CONDUCTOR WIRE¿S INSULATION. THIS FAILURE IS COMMONLY CAUSED BY MISHANDLING/MISUSE, SUCH AS COLLISION OF THE INSTRUMENT WITH A SHARP OBJECT. THE EAR OF THE DISTAL CLEVIS WAS CUT FOR INSPECTION. THERE WAS NO WELD DAMAGE FOUND. ADDITIONAL INFORMATION NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY, LIKELY CAUSED BY THE INSULATION DAMAGE. THE INSTRUMENT WAS ALSO FOUND TO HAVE INDENTATIONS ON THE EDGE OF THE DISTAL IDLER PULLEYS. THE FAILURE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE, SUCH AS INSTRUMENT COLLISIONS OR IMPACT FROM AN EXTERNAL OBJECT. BASED ON THE DEVICE EVALUATION RESULTS, THIS MDR REPORT IS BEING RETRACTED SINCE THE FAILURE MODE WAS FOUND TO BE DUE TO USER MISUSE/MISHANDLING AND NOT DUE TO A MALFUNCTION OF THE INSTRUMENT.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HEAD AND NECK SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA WAS ¿SIDE FIRING¿. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION ABOUT THE COMPLAINT: THERE WAS NO PATIENT HARM, NOTHING FELL INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A BACK UP INSTRUMENT.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE PERMANENT CAUTERY SPATULA INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. THIS COMPLAINT IS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE PERMANENT CAUTERY HOOK/ PERMANENT CAUTERY SPATULA INSTRUMENT ARCED, SMOKED, OR HAD CONDUCTOR WIRE DAMAGE WITH NO EVIDENCE OR CLAIM OF USER MISHANDLING OR MISUSE.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA WAS ¿SIDE FIRING¿. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION ABOUT THE COMPLAINT: THERE WAS NO PATIENT HARM, NOTHING FELL INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A BACK UP INSTRUMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1066680 | ENDOWRIST | PERMANENT CAUTERY SPATULA | NAY | INTUITIVE SURGICAL, INC | 470184-13 | N10190107 0097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DA VINCI INSTRUMENTS AND ACCESSORIES.| DA VINCI INSTRUMENTS AND ACCESSORIES. |