ENDOWRIST SP
Report
- Report Number
- 2955842-2024-12005
- Event Type
- Malfunction
- Date Received
- March 1, 2024
- Date of Event
- January 29, 2024
- Report Date
- February 15, 2024
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K182371
- 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 SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT WAS ANALYZED. THE INSTRUMENT WAS FOUND TO HAVE AN INSTRUMENT TUBE ADAPTER BROKEN. THE BROKEN PIECE WAS NOT RETURNED, MEASURING ROUGHLY 0.106" X 0.126" IN SIZE. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, SINGLE PORT MONOPOLAR CAUTERY INSTRUMENT HAD BROKEN DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: CONTACT PERSON REPORTED THE PART OF THE INSTRUMENT THAT BROKE WAS THE INSTRUMENT TIP. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR OTHER HARD MATERIAL DURING THE SURGICAL PROCEDURE. NO FRAGMENTS FELL INSIDE THE PATIENT. THE INSTRUMENT WAS NOT REMOVED DURING THE PROCEDURE (PRIOR TO THE BREAKAGE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310195 | ENDOWRIST SP | MONOPOLAR CAUTERY INSTRUMENT | NAY | INTUITIVE SURGICAL, INC | 430007-57 | U10220729 0008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |