ENDOWRIST
Report
- Report Number
- 2955842-2019-10858
- Event Type
- Malfunction
- Date Received
- October 29, 2019
- Date of Event
- September 20, 2019
- Report Date
- December 9, 2019
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K131861
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
Narratives
INITIAL MDR H10/H11 SUBMITTED ON 10/29/2019: 67 - INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE 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 BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: AN ISSUE WITH THE PERMANENT CAUTERY SPATULA INSTRUMENT WAS REPORTED. A WIRE "POPPED OUT" AT THE TIP; HOWEVER, THE REPORTER WAS UNABLE TO ASCERTAIN IF THE DAMAGED WIRE WAS THE CONDUCTOR WIRE OR OTHERWISE. THERE WAS NO CLAIM OF USER MISHANDLING OR MISUSE. FOLLOW-UP MDR #1 H10/11 SUBMITTED ON 11/21/2019: CORRECTED INFORMATION: SECTION D4 LOT NUMBER - N10190306. FOLLOW-UP MDR #2 H10/H11 SUBMITTED ON 12/15/2019: 67¿ INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY SPATULA INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE INVESTIGATION. VISUAL INSPECTION IDENTIFIED NO DISLODGED GRIP CABLE AND NO DAMAGE ON THE CONDUCT WIRE CABLES AT THE DISTAL TIP OF THE INSTRUMENT. 61 - ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY, CONDUCTOR WIRE CAP, AND THE DISTAL CLEVIS. FURTHER INVESTIGATION WAS PERFORMED BY REMOVING THE CLEVIS EAR AND IDENTIFIED DAMAGE ON THE CONDUCTOR WIRE INSULATION NEAR THE WELD. IT WAS INDICATED THAT THIS CONDITION WILL LIKELY CAUSE THERMAL DAMAGE ON THE DISTAL END OF THE INSTRUMENT. NO DAMAGE WAS FOUND ON THE WELD AND CONDUCTOR WIRE. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN BOSS FEATURE ON THE MONOPOLAR YAW PULLEY. THE ENTIRE BROKEN PIECE WAS RETURNED. THE KNOWN CAUSE OF THESE OBSERVATIONS ARE ATTRIBUTED TO MISHANDLING / MISUSE SUCH AS EXCESS FORCE APPLIED TO THE DISTAL END OF THE INSTRUMENT. BASED ON FAILURE ANALYSIS INVESTIGATION, THIS IS DEEMED AS A NON-REPORTABLE EVENT AND THE INITIAL MDR REPORT IS BEING RETRACTED. THE CUSTOMER REPORTED ISSUE OF A DAMAGED OR "POPPED" WIRE ON THE DISTAL END WAS NOT CONFIRMED, NO CONDUCTOR WIRE DAMAGE WAS FOUND DURING INVESTIGATION. AS PART OF EVALUATION, THE INSTRUMENT WAS FURTHER INVESTIGATED AND FOUND FAILURE OR OBSERVATIONS THAT WAS NOT REPORTED BY THE CUSTOMER. THE KNOWN COMMON CAUSE FOR THE REPORTED FAILURES ARE MISHANDLING/ MISUSE AND NOT DUE TO A MALFUNCTION OF THE DEVICE. ADDITIONALLY, THERE WAS NO REPORT OF PATIENT INJURY OR HARM. NEW ADDITIONAL/CORRECTED INFORMATION: 4307 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY SPATULA INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS FOUND THE PERMANENT CAUTERY SPATULA INSTRUMENT TO HAVE INCURRED THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY, CONDUCTOR WIRE CAP, AND DISTAL CLEVIS. THE DISTAL CLEVIS WAS REMOVED DURING FAILURE ANALYSIS FOR FURTHER INSPECTION OF THE WELD LOCATION. WHILE THE WELD WAS NOT COMPROMISED AND THE CONDUCTOR WIRE WAS NOT BROKEN, THE CONDUCTOR WIRE WAS OBSERVED TO HAVE INSULATION DAMAGE NEAR THE WELD, WHICH IS THE LIKELY CAUSE OF THE THERMAL DAMAGE TO THE INSTRUMENT. AS OF 04/11/2020, A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT. THE INITIAL REPORTER ALSO PROVIDED THE PATIENT RACE AND ETHNICITY. A LOG REVIEW CONFIRMED THAT THE REPORTED ISSUE OCCURRED ON THE INSTRUMENT¿S FOURTH USAGE ON (B)(4) ON 09/20/2019. 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 PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR. THE FOLLOWING WAS FOUND DURING THE DEVICE EVALUATION, BUT IS NOT RELATED TO THE REPORTABLE FINDING: THE INSTRUMENT WAS ALSO FOUND TO HAVE A BROKEN BOSS FEATURE ON THE MONOPOLAR YAW PULLEY. THE BROKEN PIECE WAS RETURNED WITH THE INSTRUMENT. THIS FAILURE IS MOST COMMONLY CAUSED BY MISHANDLING/MISUSE, SUCH AS EXCESS FORCE APPLIED TO THE DISTAL END OF THE INSTRUMENT. UPDATED FIELDS: 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 BEEN POPULATED AS IT WAS BLANK IN THE PREVIOUS REPORTS. G1 AND G2 HAVE BEEN UPDATED AS THE MANUFACTURER'S CONTACT INFORMATION HAS CHANGED. 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 "REUSE" AS THE INVESTIGATION REVEALED THAT THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S FOURTH USAGE. THIS REPORT HAS BEEN GENERATED IN RESPONSE TO FDA INSPECTIONAL OBSERVATIONS DATED 06-MAR-2020.
CORRECTED INFORMATION: SECTION D4 LOT NUMBER - N10190306.
67¿ INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE INVESTIGATION. VISUAL INSPECTION IDENTIFIED NO DISLODGED GRIP CABLE AND NO DAMAGE ON THE CONDUCT WIRE CABLES AT THE DISTAL TIP OF THE INSTRUMENT. 61 - ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE: THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY, CONDUCTOR WIRE CAP, AND THE DISTAL CLEVIS. FURTHER INVESTIGATION WAS PERFORMED BY REMOVING THE CLEVIS EAR AND IDENTIFIED DAMAGE ON THE CONDUCTOR WIRE INSULATION NEAR THE WELD. IT WAS INDICATED THAT THIS CONDITION WILL LIKELY CAUSE THERMAL DAMAGE ON THE DISTAL END OF THE INSTRUMENT. NO DAMAGE WAS FOUND ON THE WELD AND CONDUCTOR WIRE. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE A BROKEN BOSS FEATURE ON THE MONOPOLAR YAW PULLEY. THE ENTIRE BROKEN PIECE WAS RETURNED. THE KNOWN CAUSE OF THESE OBSERVATIONS ARE ATTRIBUTED TO MISHANDLING / MISUSE SUCH AS EXCESS FORCE APPLIED TO THE DISTAL END OF THE INSTRUMENT. BASED ON FAILURE ANALYSIS INVESTIGATION, THIS IS DEEMED AS A NON-REPORTABLE EVENT AND THE INITIAL MDR REPORT IS BEING RETRACTED. THE CUSTOMER REPORTED ISSUE OF A DAMAGED OR "POPPED" WIRE ON THE DISTAL END WAS NOT CONFIRMED, NO CONDUCTOR WIRE DAMAGE WAS FOUND DURING INVESTIGATION. AS PART OF EVALUATION, THE INSTRUMENT WAS FURTHER INVESTIGATED AND FOUND FAILURE OR OBSERVATIONS THAT WAS NOT REPORTED BY THE CUSTOMER. THE KNOWN COMMON CAUSE FOR THE REPORTED FAILURES ARE MISHANDLING/ MISUSE AND NOT DUE TO A MALFUNCTION OF THE DEVICE. ADDITIONALLY, THERE WAS NO REPORT OF PATIENT INJURY OR HARM.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL TUMOR RESECTION PROCEDURE, THE SURGEON OBSERVED THAT A WIRE "POPPED OUT" FROM THE PERMANENT CAUTERY HOOK INSTRUMENT TIP AND AT THE "INSULATOR PART." THE REPORTER STATED THAT AT THE TIME OF THE EVENT, TISSUE WAS TOUCHED AND ENERGIZED. IT WAS NOTED THAT "INTRAOPERATIVE SUPPORT WAS CONDUCTED WITH CONTINUED USE OF THE INSTRUMENT." THE USER CONTINUED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ALL THE INSTRUMENTS AND ACCESSORIES WERE INSPECTED PRIOR TO USE AND NO ISSUE WAS FOUND. DURING THE PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT WAS USED TO REMOVE FAT TISSUE AROUND THE TUMOR. THERE WAS NO KNOWN INSTRUMENT COLLISION. INSTRUMENT ARCING WAS NOT OBSERVED DURING THIS PROCEDURE. ALTHOUGH AN ISSUE WITH THE INSTRUMENT WAS OBSERVED, THE INSTRUMENT WAS USED TO CONTINUE THE CASE. THERE WAS NO KNOWN PATIENT CONSEQUENCE OR INJURY DUE TO THIS ISSUE. THE PROCEDURE WAS COMPLETED WITH NO OTHER ISSUE REPORTED.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE 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 BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: AN ISSUE WITH THE PERMANENT CAUTERY HOOK INSTRUMENT WAS REPORTED. A WIRE "POPPED OUT" AT THE TIP; HOWEVER, THE REPORTER WAS UNABLE TO ASCERTAIN IF THE DAMAGED WIRE WAS THE CONDUCTOR WIRE OR OTHERWISE. THERE WAS NO CLAIM OF USER MISHANDLING OR MISUSE.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MEDIASTINAL TUMOR RESECTION PROCEDURE, THE SURGEON OBSERVED THAT A WIRE "POPPED OUT" FROM THE PERMANENT CAUTERY HOOK INSTRUMENT TIP AND AT THE "INSULATOR PART." THE REPORTER STATED THAT AT THE TIME OF THE EVENT, TISSUE WAS TOUCHED AND ENERGIZED. IT WAS NOTED THAT "INTRAOPERATIVE SUPPORT WAS CONDUCTED WITH CONTINUED USE OF THE INSTRUMENT." THE USER CONTINUED THE PROCEDURE WITH NO FURTHER ISSUE REPORTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: ALL THE INSTRUMENTS AND ACCESSORIES WERE INSPECTED PRIOR TO USE AND NO ISSUE WAS FOUND. DURING THE PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT WAS USED TO REMOVE FAT TISSUE AROUND THE TUMOR. THERE WAS NO KNOWN INSTRUMENT COLLISION. INSTRUMENT ARCING WAS NOT OBSERVED DURING THIS PROCEDURE. ALTHOUGH AN ISSUE WITH THE INSTRUMENT WAS OBSERVED, THE INSTRUMENT WAS USED TO CONTINUE THE CASE. THERE WAS NO KNOWN PATIENT CONSEQUENCE OR INJURY DUE TO THIS ISSUE. THE PROCEDURE WAS COMPLETED WITH NO OTHER ISSUE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1046789 | ENDOWRIST | PERMANENT CAUTERY SPATULA | NAY | INTUITIVE SURGICAL, INC | 470184-13 | N10190306 0098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DA VINCI INSTRUMENTS AND ACCESSORIES| DA VINCI INSTRUMENTS AND ACCESSORIES |