NONE
Report
- Report Number
- 2955842-2022-12007
- Event Type
- Malfunction
- Date Received
- June 3, 2022
- Date of Event
- May 4, 2022
- Report Date
- May 4, 2022
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 10886874111045
- PMA / PMN Number
- K112263
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ISI HAS NOT RECEIVED THE MCS INSTRUMENT AND MCS TIP COVER ACCESSORY INVOLVED WITH THIS COMPLAINT. THEREFORE, THE ROOT CAUSE OF THE ALLEGED CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCTS ARE RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE SYSTEM AND INSTRUMENT LOGS HAS BEEN PERFORMED. THERE WERE NO OBSERVED EVENTS IN THE AVAILABLE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE, AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE MCS TIP COVER ACCESSORY BURNED THROUGH, ALLOWING DIATHERMY TO ARC DURING MESORECTUM DISSECTION. PERITONEUM TISSUE OVERLYING THE PELVIC BRIM WAS BURNED. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE BURNT TISSUE. THE PATIENT DID NOT REQUIRE PROLONGED HOSPITALIZATION AND THE SURGEON DOES NOT HAVE ANY CONCERN ABOUT THIS EVENT CAUSING LONG TERM COMPLICATION IN THE PATIENT. THE SURGEON BELIEVES THE CAUSE OF THE ARCING WAS DEGRADATION OF THE MCS TIP COVER ACCESSORY. THE MCS TIP COVER ACCESSORY WAS REPLACED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY USING THE SAME MCS INSTRUMENT.
ON MAY 15 2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM FAILURE ANALYSIS OF THE MONOPOLAR CURVED SCISSORS (MCS): THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE TIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY AND ENERGY DELIVERY TESTS. NO SIGNS OF THERMAL DAMAGE FOUND. ADDITIONAL OBSERVATION NOT REPORTED BY SITE THAT IS NOT RELATED TO THE CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT TUBE EXTENSION EXHIBITS SIGNS OF SCRATCH MARKS/ABRASIONS. TUBE EXTENSION SCRATCH MARKS MEASURED ROUGHLY .224¿ X .025¿.
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE CENTER OF THE MCS TIP COVER ACCESSORY EXHIBITED LOCALIZED MELTING, WHICH IS REGULARLY INDICATIVE OF ARCING. HOWEVER, THE THERMAL DAMAGE IS NOT ON THE DISTAL END, WHICH INDICATES THE THERMAL DAMAGE WAS LIKELY CAUSED BY ANOTHER ENERGIZED INSTRUMENT OTHER THAN THE ONE THAT THE TIP COVER WAS INSTALLED ONTO. THE SITE DID NOT RETURN THE MCS INSTRUMENT THAT IS BELIEVED TO HAVE BEEN USED IN CONJUNCTION WITH THE MCS TIP COVER ACCESSORY. THEREFORE, THE MCS TIP COVER ACCESSORY COULD NOT BE INSTALLED ON THE MCS INSTRUMENT TO OBSERVE IF THE HOLES POSITION ALIGNED WITH THE MCS INSTRUMENT. NO PIECES OF THE MCS TIP COVER ACCESSORY WERE MISSING. THE ROOT CAUSE OF THERMAL DAMAGE TO THE MCS TIP COVER ACCESSORY IS TYPICALLY ATTRIBUTED TO MISHANDLING/MISUSE.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION PROCEDURE, THE TIP COVER OF THE MONOPOLAR CURVED SCISSORS (MCS) BURNED THROUGH, ALLOWING DIATHERMY TO ARC. THE PATIENT WAS BURNED INTERNALLY. THE MCS TIP COVER ACCESSORY WAS REPLACED AND THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE ROBOTICS COORDINATOR AND OBTAINED THE FOLLOWING INFORMATION: THE ARCING OCCURRED FROM THE SCISSOR TIP AND GROUNDED ON THE MCS TIP COVER ACCESSORY, WHERE THE HOLES WERE. AFTER THE ARCING EVENT, THERE WAS DAMAGE TO THE MCS TIP COVER ACCESSORY WHERE HOLES APPEARED, BUT THERE WAS NO DAMAGE TO THE MCS INSTRUMENT. THE SURGEON WAS CUTTING WITH DIATHERMY WHEN THE INCIDENT OCCURRED. THE MCS WAS CONNECTED PROPERLY VIA A MONOPOLAR CORD. THE GENERATOR USED WAS AN ERBE VIO DV, THE SETTINGS WERE: CUT: 4, COAG: 4. THE MCS WAS USED FOR 2 HOURS BEFORE THE INCIDENT OCCURRED. AT THE TIME OF THE ARCING, THE FORCE BIPOLAR AND TIP-UP FENESTRATED GRASPER WERE THE OTHER INSTRUMENTS IN USE. THE MCS INSTRUMENT TIP WAS IN CONTACT WITH TISSUE WHEN THE INSTRUMENT WAS ACTIVATED. THERE WAS NO COLLISION OF INSTRUMENTS, THE INSTRUMENT WAS NOT IMMERSED IN LIQUID AND ITS JAWS NOT CONTAMINATED BY CARBONIZED TISSUE WHEN THE ARCING INCIDENT OCCURRED. THE PATIENT SUSTAINED A "MINOR INJURY" DUE TO THE ARCING. TISSUE WAS CHARRED AT AN UNINTENDED LOCATION. THE BURN MARKS SEEN WERE NOT AROUND THE CANNULA/ INCISION PORTS. THE GROUNDING PAD WAS PLACED ON THE RIGHT THIGH AND THERE WERE NO DEFECTS SEEN. THE SURGEON USED A BACKUP MCS TIP COVER ACCESSORY INSTALLED ON THE SAME MCS AND CONTINUED THE PROCEDURE. THERE WERE NO FURTHER ISSUES AND NO POST-OPERATIVE COMPLICATIONS IN THE PATIENT. ISI FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: THE SURGEON WAS DISSECTING MESORECTUM WHEN THE ARCING INCIDENT OCCURRED. PERITONEUM OVERLYING THE PELVIC BRIM WAS BURNED. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE BURNT TISSUE. THE PATIENT DID NOT REQUIRE PROLONGED HOSPITALIZATION AND THE SURGEON DOES NOT HAVE ANY CONCERN ABOUT THIS EVENT CAUSING LONG TERM COMPLICATION IN THE PATIENT. THE MCS TIP COVER ACCESSORY WAS INSTALLED PROPERLY, THE FORCE BIPOLAR INSTRUMENT WAS NOT TOO CLOSE TO THE MCS DURING THE ARCING INCIDENT, AND THERE WAS NO DAMAGE NOTED ON THE MCS TIP COVER ACCESSORY PRIOR TO THE ARCING EVENT. THE SURGEON BELIEVES THE CAUSE OF THE ARCING WAS DUE TO DEGRADATION OF THE MCS TIP COVER ACCESSORY.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1555999 | NONE | TIP COVER ACCESSORY | NAY | INTUITIVE SURGICAL, INC | 400180-14 | M90211129 | 10886874111045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |