ENDOWRIST
Report
- Report Number
- 2955842-2025-16744
- Event Type
- Malfunction
- Date Received
- April 24, 2025
- Date of Event
- March 31, 2025
- Report Date
- March 31, 2025
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 10886874114817
- PMA / PMN Number
- K162973
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
Narratives
INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SUCTION IRRIGATOR INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS FOUND TO HAVE A BROKEN MAIN TUBE AT THE DISTAL END. THE MAIN TUBE IS DETACHED FROM THE DISTAL END OF THE INSTRUMENT. NO MATERIAL WAS FOUND MISSING. COMPONENTS ADJACENT TO THIS BROKEN MAIN TUBE DO SHOW DAMAGE. THE SNAKE WRIST IS DISLODGED, THE INNER LUMEN IS BROKEN AND SNAKE WRIST CABLE IS BROKEN. ADDITIONAL OBSERVATIONS RELATED TO CUSTOMER REPORTED COMPLAINT: THE INSTRUMENT WAS FOUND TO HAVE A BROKEN INNER LUMEN AT THE DISTAL END. THE ROOT CAUSE IS ATTRIBUTED TO THE USER. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN SNAKE WRIST CABLE AT THE DISTAL END. TWO OF THE CABLES WERE FULLY BROKEN. THERE WAS NO EVIDENCE OF DISCOLORATION OR CORROSION/CONTAMINATION ON THE CABLES TO INDICATE A REPROCESSING INDUCED ISSUE. THE COMPONENTS SURROUNDING THE BROKEN CABLE DID EXHIBIT DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE CABLE BREAKING. THE MAIN TUBE IS BROKEN, THE INNER LUMEN IS BROKEN AND SNAKE WRIST IS DISLODGED. THE INSTRUMENT WAS FOUND TO HAVE A DISLODGED SNAKE WRIST AT THE WRIST DISK END CAP, WHICH CAUSED THE WRIST DISKS TO MISALIGN. THERE WERE NO MISSING PIECES, AND DAMAGE WAS OBSERVED TO THE SNAKE WRIST CABLES. WRIST ASSEMBLY IS NOT STRAIGHT AND DID ADVANCE THROUGH A CANNULA. OTHER COMPONENTS ADJACENT TO THE DISLODGED SNAKE WRIST DO SHOW DAMAGE WHICH MAY INDICATE POTENTIAL MISHANDLING AND MISUSE. THE MAIN TUBE IS BROKEN, THE INNER LUMEN IS BROKEN AND SNAKE WRIST CABLE IS BROKEN. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE USER. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.
CORRECTION TO SECTION D: PRIMARY PRODUCT BATCH/LOT NUMBER WAS UPDATED TO K112412060199.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED WHILE IN USE INSIDE OF THE PATIENT A WIRE AT DISTAL TIP OF THE ROBOTIC SUCTION IRRIGATOR SNAPPED - SUCTION TIP THEREFORE BROKE OFF. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS COMPLETING AS PLANNED A WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: FOLLOW-UP: ON (B)(6) 2025, THE NURSE INFORMED THE INSTRUMENT WAS INSPECTED PRIOR TO PROCEDURE WITH NO DAMAGED NOTED. THEY WERE SUCTIONING AT THE TIME OF THE ISSUE; THERE WERE NO FRAGMENTS THAT FELL INTO THE PATIENT. THE INSTRUMENT TIP SNAPPED. THERE WERE NO FRAGMENTS BROKE OFF. THE INSTRUMENT WILL BE RETURNED. THE CASE WAS COMPLETED ROBOTICALLY. THE PATIENT DEMOGRAPHICS WERE PROVIDED.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 706515 | ENDOWRIST | SUCTION IRRIGATOR | NAY | INTUITIVE SURGICAL, INC | 480299-06 | K11241206 0199 | 10886874114817 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Female | DA VINCI INSTRUMENTS AND ACCESSORIES. |