ENDOWRIST
Report
- Report Number
- 2955842-2025-23061
- Event Type
- Malfunction
- Date Received
- May 30, 2025
- Date of Event
- April 23, 2025
- Report Date
- October 29, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874119815
- PMA / PMN Number
- K214095
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS AND THE COMPLAINT WAS CONFIRMED. THE MEGA SUTURECUT NEEDLE DRIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A FRAYED GRIP CABLE AT THE IDLER PULLEY LOCATION. THE CABLE WAS FRAYED, BUT THE CABLE WAS NOT FULLY BROKEN. SOME BUNDLES OF THE FRAYED CABLE STRANDS STUCK OUT AT THE WRIST. THERE WAS NO EVIDENCE OF DISCOLORATION OR CORROSION/CONTAMINATION ON THE CABLES TO INDICATE A REPROCESSING INDUCED ISSUE. FURTHER INSPECTION FOUND NO ABNORMALLY SHARP OR DAMAGED COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE CABLE BREAKING. ADDITIONAL RELATED OBSERVATION: THE INSTRUMENT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND DRIVEN. THE INSTRUMENT EXHIBITED IMPRECISE MOTION IN THE YAW DIRECTION. THE GRIP TIPS MOVED IN THE DIRECTION COMMANDED, HOWEVER A LAG OR DELAY IN THE MOTION WAS OBSERVED. THE PROBABLE ROOT CAUSE OF CABLE BREAKAGE, WHETHER PARTIAL OR FULL, IS ATTRIBUTED TO DAMAGE TO THE CABLE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING. THE PROBABLE ROOT CAUSE OF IMPRECISE MOTION OBSERVED IS ATTRIBUTED TO THE PRIMARY FAILURE OF INSTRUMENT FRAYED GRIP CABLE ON THE DISTAL END. PLEASE REFER TO THE FOLLOWING FIELDS FOR CORRECTED INFORMATION: FIELD D. SUSPECT MEDICAL DEVICE PRODUCT INFORMATION CHANGED FROM MONOPOLAR CURVED SCISSORS TO MEGA SUTURECUT NEEDLE DRIVER. G4: PMA/510K NUMBER: K214095. H4: DEVICE MANUFACTURE DATE: 12/05/2024. BASED ON ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THE INSTRUMENT INVOLVED WITH THIS COMPLAINT DOES NOT MEET THE CRITERIA FOR FIELD ACTION# ISIFA2024-09-C, AS PREVIOUSLY LISTED IN SECTION H9.
AT THIS TIME, THE COMPLAINT INVESTIGATION TO DETERMINE THE CAUSE OF THIS REPORTED EVENT IS CURRENTLY IN PROGRESS. AS SUCH, THE PROBABLE ROOT CAUSE CANNOT YET BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE COMPLAINT WILL BE REEVALUATED AT INVESTIGATION COMPLETION.
THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS FURTHER EVALUATED BY FAILURE ANALYSIS ENGINEER (FAE). DURING IN-HOUSE HANDLING, THE GRIP CABLE WAS COMPLETELY BROKEN, WHICH WAS NOT OBSERVED INITIALLY WHEN RECEIVED BY CUSTOMER. THE BLADES WERE INSPECTED AND THERE WERE NO SIGNIFICANT INDENTATIONS THAT WOULD LEAD TO THE BLADES NOT BEING ABLE TO CLOSE. THE INSTRUMENT WAS DISASSEMBLED AND INSPECTED. THERE WERE NO LOOSE PULLEY SCREWS, AND THE CABLES WERE ALL THE SAME LENGTH. FURTHERMORE, THE CRIMPS ON THE PITCH CABLE'S HYPOTUBES ARE PRESENT AND THE CABLES DID NOT MOVE OUT OF THEIR RESPECTIVE HYPOTUBES WHEN MANUALLY PULLED. THUS, THE FRAYED GRIP CABLES LIKELY LEAD TO THE IMPRECISE MOTION SINCE IT IS PLAUSIBLE THAT THE FRAYED GRIP CABLES LEAD TO A LOOSE IN TENSION TO THE GRIP. CORRECTION(S): H8. WAS UPDATED TO INITIAL USE OF DEVICE.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT THERE WAS A LIMITED OR IMPRECISE MOTION ISSUE WITH A DA VINCI PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642830 | ENDOWRIST | MEGA SUTURECUT ND | NAY | INTUITIVE SURGICAL, INC | 471309-17 | K12241205 0447 | 00886874119815 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |