ENDOWRIST
Report
- Report Number
- 2955842-2023-18422
- Event Type
- Malfunction
- Date Received
- September 13, 2023
- Date of Event
- August 1, 2023
- Report Date
- August 21, 2023
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- GDW
- PMA / PMN Number
- K140553
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.
THE GREEN SUREFORM 45 RELOAD HAD BEEN EVALUATED BY THE ADVANCED FAILURE ANALYSIS (AFA) TEAM. VISUAL INSPECTION CONFIRMED THAT THE BLADE WAS EXPOSED WHILE THE FIRING WAS AT APPROXIMATELY 80% COMPLETION, WHICH ALIGNS WITH THE COMPLETION PERCENTAGE IN THE LOGS OF ~84%. THE PEAK FIRE TORQUE RECORDED DURING THE FIRING WAS 144 MNM, WHICH WAS OVER THE FIRE TORQUE LIMIT OF 134.25 MNM. AN ADDITIONAL OBSERVATION FOUND WAS THAT THE LEADSCREW HAD DAMAGE TO THE THREADS IN THE FIRED SECTION OF THE LEADSCREW. METAL SHAVINGS FROM THE LEADSCREW WERE FOUND IN THE CARTRIDGE AND ON AND AROUND THE LEADSCREW AND SHUTTLE. ADDITIONALLY, THE KNIFE WAS FOUND TO BE ROTATED BACKWARDS, AS THE BACK EXTRUSION PIN BECAME DISLODGED FROM THE CARTRIDGE SLOT. THE KNIFE EDGE EXHIBITED MULTIPLE MECHANICAL INDENTATIONS, LIKELY DUE TO INTERACTION WITH A HARD OBSTRUCTION. THE INNER CARTRIDGE SURFACE EXHIBITED A SECTION WITH SKIVING CAUSED BY THE KNIFE LUG DIGGING INTO THE CARTRIDGE DURING FIRING. EVIDENCE SUGGESTED THAT THE RELOAD WAS FIRED ACROSS AN OBSTRUCTION OR SOMETHING CAUSING HIGH RESISTANCE, RESULTING IN KNIFE ROTATION, CARTRIDGE SKIVING, AND DAMAGE TO THE LEADSCREW.
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE GREEN SUREFORM 45 RELOAD TO PERFORM FAILURE ANALYSIS. THE GREEN SUREFORM 45 RELOAD WAS ANALYZED AND FOUND TO HAVE THE KNIFE EXPOSED WITHIN THE KNIFE TRACK. THE RELOAD WAS FOUND TO HAVE A FIRING FAILURE BASED ON LOG REVIEW AND DURING IN-HOUSE INSPECTION. THE RELOAD PARTIAL FIRE LOG REVIEW SHOWED THAT THE RELOAD WAS USED DURING A RIGHT HEMICOLECTOMY PROCEDURE WHERE THE PARTIAL FIRE WAS COMPLETED TO 84.89%. THE LOGS SHOWED THAT THE FIRING NUMBER OF THE PARTIAL FIRE BY THE INSTRUMENT IN THE PROCEDURE WAS THE 5TH FIRE. THE CLAMP HISTORY OF THE INSTRUMENT IN THE PROCEDURE WITH THE PARTIAL FIRE SHOWED THAT THE INSTRUMENT WAS CLAMPED 21 TIMES. ADDITIONALLY, THE RELOAD WAS FOUND TO HAVE LODGED STAPLES IN THE KNIFE TRACK. THE LODGED STAPLES WERE WRAPPED AROUND THE EXPOSED BLADE. THE RELOAD WAS ALSO FOUND TO HAVE CARTRIDGE DAMAGE. THERE WAS NO MISSING MATERIAL. SIGN OF CORROSION WAS FOUND ON THE LEAD SCREW.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT JAMMED DUE TO A STAPLE STUCK IN THE GROOVE. THE GREEN SUREFORM 45 RELOAD WAS UNABLE TO STAPLE CUT TISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE PROCEDURE WAS COMPLETED ROBOTICALLY AS PLANNED.
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 |
|---|---|---|---|---|---|---|---|
| 2061092 | ENDOWRIST | STAPLER 45 RELOAD | GDW | INTUITIVE SURGICAL, INC | 48445G-04 | M90211114 0676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES. |