ENDOWRIST
Report
- Report Number
- 2955842-2019-10872
- Event Type
- Malfunction
- Date Received
- November 4, 2019
- Date of Event
- October 31, 2019
- Report Date
- November 18, 2019
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874111536
- PMA / PMN Number
- K050369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 HOOK 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 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 INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION ABOUT THE COMPLAINT: BOTH THE PERMANENT CAUTERY HOOK INSTRUMENT AND THE TROCAR WERE INSPECTED PRIOR TO USE. THE SURGICAL TASK BEING PERFORMED WHEN THE SPARKING EVENT OCCURRED WAS MESORECTUM PREPARATION. THE FENESTRATED BIPOLAR FORCEPS AND PROGRASP FORCEPS WERE ALSO BEING USED WHEN THE EVENT OCCURRED. THERE WERE NO INSTRUMENT COLLISIONS. THERE WAS NO INJURY TO THE PATIENT. FOLLOW-UP MDR #2 H10/H11 SUBMITTED ON(B)(6)2019 : ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: D10, G4, G7, H2, H3, H6 AND H10. 61 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED ISSUE. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY AND PROXIMAL CLEVIS. BLACK CHAR MARKS WERE PRESENT AT THE DISTAL END. ANY MATERIAL MISSING FROM THE DAMAGE OF THE YAW PULLEY WAS LIKELY THERMALLY INDUCED RATHER THAN MECHANICALLY INDUCED. THE KNOWN COMMON CAUSE OF THIS FAILURE WAS MISHANDLING/MISUSE. ONE SIDE OF THE DISTAL CLEVIS EAR WAS REMOVED AND THE SILICONE POTTING DID NOT APPEAR TO BE COMPROMISED. THE CONDUCTOR WIRE WAS NOT DAMAGED AROUND THE WELD LOCATION. THE ELECTRICAL CONTINUITY TEST PASSED. ADDITIONAL OBSERVATION NOT REPORTED WAS THE INSTRUMENT HAD A DISLODGED SLEEVE AND NO MISSING MATERIAL. 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, G4, G5, G7, H2, H5, H6, H8 AND H10. INTUITIVE SURGICAL, INC. (ISI) CONTACTED AN ISI CLINICAL SALES REPRESENTATIVE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A BACKUP PERMANENT CAUTERY HOOK INSTRUMENT WAS INSTALLED TO CONTINUE WITH THE PROCEDURE. THERE WAS NO HARM, INJURY, OR ADVERSE OUTCOME TO THE PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS AS A RESULT OF THE ARCING EVENT. A VALLEYLAB ELECTROSURGICAL GENERATOR UNIT (ESU) WAS IN USE. THE ARCING OCCURRED WHILE THE INSTRUMENT¿S TIP WAS IN CONTACT WITH TISSUE. 4307 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT AND PERFORMED A DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE REPORTED COMPLAINT AND FOUND THE PERMANENT CAUTERY HOOK INSTRUMENT TO HAVE INCURRED THERMAL DAMAGE TO THE MONOPOLAR YAW PULLEY AND PROXIMAL CLEVIS. BLACK CHAR MARKS WERE PRESENT AT THE DISTAL END. IT WAS NOTED THAT ANY MATERIAL MISSING FROM THE DAMAGE IS LIKELY THERMALLY INDUCED RATHER THAN MECHANICALLY INDUCED. ADDITIONALLY, THE PERMANENT CAUTERY HOOK INSTRUMENT¿S CERAMIC SLEEVE WAS FOUND TO BE DISLODGED. ONE SIDE OF THE CLEVIS EAR WAS REMOVED FOR INSPECTION OF THE WELD LOCATION. THE SILICONE POTTING DID NOT APPEAR TO BE COMPRISED AND THE CONDUCTOR WIRE WAS NOT DAMAGED. THE INSTRUMENT PASSED AN ELECTRICAL CONTINUITY TEST. (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 SIXTH USAGE ON 10/31/2019 ON SH2066. 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 THERMAL DAMAGE PROXIMAL TO THE CERAMIC SLEEVE IS EVIDENCE OF 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. 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/G5: THE PRODUCT CATALOG NUMBER AND PMA/510K NUMBER HAVE BEEN POPULATED AS THEY WERE 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 "REUSE" AS THE INVESTIGATION REVEALED THAT THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S SIXTH 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 10 USAGES ALLOTTED TO IT, WHICH ARE TRACKED BY THE DA VINCI SURGICAL SYSTEM. THIS REPORTED ISSUE OCCURRED ON THE INSTRUMENT'S SIXTH 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
ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: G4, G7, H2 AND H10. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION ABOUT THE COMPLAINT: BOTH THE PERMANENT CAUTERY HOOK INSTRUMENT AND THE TROCAR WERE INSPECTED PRIOR TO USE. THE SURGICAL TASK BEING PERFORMED WHEN THE SPARKING EVENT OCCURRED WAS MESORECTUM PREPARATION. THE FENESTRATED BIPOLAR FORCEPS AND PROGRASP FORCEPS WERE ALSO BEING USED WHEN THE EVENT OCCURRED. THERE WERE NO INSTRUMENT COLLISIONS. THERE WAS NO INJURY TO THE PATIENT.
61 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED ISSUE. THE INSTRUMENT WAS FOUND TO HAVE THERMAL DAMAGE ON THE MONOPOLAR YAW PULLEY AND PROXIMAL CLEVIS. BLACK CHAR MARKS WERE PRESENT AT THE DISTAL END. ANY MATERIAL MISSING FROM THE DAMAGE OF THE YAW PULLEY WAS LIKELY THERMALLY INDUCED RATHER THAN MECHANICALLY INDUCED. THE KNOWN COMMON CAUSE OF THIS FAILURE WAS MISHANDLING/MISUSE. ONE SIDE OF THE DISTAL CLEVIS EAR WAS REMOVED AND THE SILICONE POTTING DID NOT APPEAR TO BE COMPROMISED. THE CONDUCTOR WIRE WAS NOT DAMAGED AROUND THE WELD LOCATION. THE ELECTRICAL CONTINUITY TEST PASSED. ADDITIONAL OBSERVATION NOT REPORTED WAS THE INSTRUMENT HAD A DISLODGED SLEEVE AND NO MISSING MATERIAL. 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 LOW ANTERIOR RESECTION PROCEDURE, THE PERMANENT CAUTERY HOOK INSTRUMENT STOPPED COAGULATING AND SPARKED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED HARM, INJURY, OR ADVERSE OUTCOME. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION ABOUT THE COMPLAINT: BOTH THE PERMANENT CAUTERY HOOK INSTRUMENT AND THE TROCAR WERE INSPECTED PRIOR TO USE. THE SURGICAL TASK BEING PERFORMED WHEN THE SPARKING EVENT OCCURRED WAS MESORECTUM PREPARATION. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT AND PROGRASP FORCEPS INSTRUMENT WERE ALSO BEING USED WHEN THE EVENT OCCURRED. THERE WERE NO INSTRUMENT COLLISIONS. THERE WAS NO INJURY TO THE PATIENT.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
INTUITIVE SURGICAL, INC. (ISI) HAS NOT YET RECEIVED THE PERMANENT CAUTERY HOOK 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 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 LOW ANTERIOR RESECTION PROCEDURE, THE PERMANENT CAUTERY HOOK STOPPED COAGULATING AND SPARKED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1070718 | ENDOWRIST | PERMANENT CAUTERY HOOK | NAY | INTUITIVE SURGICAL, INC | 420183-12 | N10180126 454 | 00886874111536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DA VINCI INSTRUMENTS AND ACCESSORIES| DA VINCI INSTRUMENTS AND ACCESSORIES |