ENDOWRIST SP
Report
- Report Number
- 2955842-2023-19967
- Event Type
- Malfunction
- Date Received
- November 6, 2023
- Date of Event
- September 11, 2023
- Report Date
- October 16, 2023
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874114339
- PMA / PMN Number
- K182371
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
CORRECT INFORMATION: REPORTABLE EVENT: POTENTIAL FRAGMENT INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SINGLE-PORT FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT WAS ANALYZED. THE INSTRUMENT WAS FOUND TO HAVE DAMAGE OF THE CONDUCTOR WIRE¿S INSULATION. THE CONDUCTOR WIRE WAS FOUND NICKED WITH NO EXPOSED INTERNAL WIRE. NO THERMAL DAMAGE WAS OBSERVED AND NO MISSING PIECE OF THE INSULATION. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TEST. FOR CLARIFICATION, THE CONDUCTOR WIRE VISUALLY LOOKS LOOSE DUE TO THE BROKEN MOLDED INSULATOR. ADDITIONALLY, INVESTIGATION FOUND A BROKEN MOLDED INSULATOR. THE MOLDED INSULATOR WAS ATTACHED TO ONE OF THE INSTRUMENT GRIPS. THE BROKEN MOLDED INSULATOR HAD A MISSING MATERIAL APPROXIMATELY 0.055" X 0.344" IN SIZE, AND THIS PIECE WAS NOT RETURNED. A PIECE OF MATERIAL WAS RETURNED WITH THE INSTRUMENT APPROXIMATELY 0.072" X 0.073" IN SIZE. THE METAL GRIP WAS STILL PRESENT/ATTACHED TO THE INSTRUMENT GRIP TIPS. 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. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SINGLE-PORT SHEATH, WHICH WAS RETURNED WITH THE SINGLE-PORT FBF INSTRUMENT, AND COMPLETED THE DEVICE EVALUATION. THERE WAS NO REPORTED COMPLAINT AGAINST THE SHEATH. VISUAL INSPECTION WAS PERFORMED, AND NO DAMAGE WAS FOUND. NO PRODUCT ISSUE WAS IDENTIFIED.
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 PRODUCT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.
INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS BROKEN INTO SMALL PIECES AND FELL INTO THE PATIENT. THE SURGEON REMOVED THE FRAGMENTS DURING THE SAME PROCEDURE. THE SURGEON CONFIRMED THAT ALL FRAGMENTS WERE REMOVED. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETENTION OF FOREIGN MATERIAL. ISI RECEIVED A VIDEO CLIP RELATED TO THE ALLEGED COMPLAINT AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: IT WAS CONFIRMED THAT THERE WERE FRAGMENTS OF MATERIAL WITHIN THE GRIPS OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT. THE SURGEON USED THE NEEDLE DRIVER TO ATTEMPT TO CLEAN OFF THE FRAGMENT FROM WITHIN THE FBF JAWS, LAUNCHING THE FRAGMENT ONTO THE PATIENT'S TISSUE. THE MOLDED INSULATOR COMPONENT ON THE FBF GRIP BECAME DISLODGED BUT REMAINED INTACT TO THE REST OF THE INSTRUMENT. THE FBF WAS REMOVED AT TIMESTAMP 01:54. A LAPAROSCOPIC GRASPER WAS USED TO RETRIEVE FRAGMENTS FROM THE SURGICAL SCENE, BUT FROM THE VIDEO, IT WAS UNABLE TO IDENTIFY THE FRAGMENTS MATERIAL AND IF THEY WERE PRODUCED FROM THE FBF. WITHOUT SIMULTANEOUS VIDEO OF THE LAP GRASPER BEING REMOVED FROM THE PATIENT WITH THE FRAGMENTS, IT WAS UNABLE TO CONFIRM IF ALL FRAGMENTS WERE RETRIEVED. HOWEVER, FAILURE ANALYSIS RESULTS SHOWED THAT ONE PIECE OF MATERIAL WAS RETURNED WITH THIS INSTRUMENT. THROUGHOUT THE VIDEO, THE SURGEON WAS USING OTHER INSTRUMENTS TO CLEAN THE GRIPS OF THE FBF INSTRUMENT, WHICH WAS NOT ADVISED IN THE SP INSTRUMENTS AND ACCESSORIES USER MANUAL, AS THIS COULD LEAD TO INSTRUMENT DAMAGE OR TISSUE INJURY.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CONDUCTOR WIRE OF THE SINGLE-PORT FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT WAS DAMAGED. THE CUSTOMER USED A BACKUP FBF INSTRUMENT TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341095 | ENDOWRIST SP | FENESTRATED BIPOLAR FORCEPS | NAY | INTUITIVE SURGICAL, INC | 430011-57 | U10230130 0012 | 00886874114339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |