NONE
Report
- Report Number
- 2955842-2026-00075
- Event Type
- Malfunction
- Date Received
- January 6, 2026
- Date of Event
- December 4, 2025
- Report Date
- April 16, 2026
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- UDI-DI
- 00886874116555
- PMA / PMN Number
- K191736
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- 003
Narratives
INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION: THE INCIDENT LAST OCCURRED WITH A ROBOTIC ASSISTED CHOLECYSTECTOMY. WHEN PLACING THE ENDOSCOPE INTO MAIN PORT FOR VISUAL ACCESS, THE PICTURE ON DAVINCI TOWER WAS DISPLAYING BACKWARDS. PATIENT TISSUE WAS DISPLAYING "FLIPPED" NOT IN THE RIGHT ORIENTATION. RIGHT SIDE TISSUE WAS DISPLAYING ON THE LEFT ETC. AFTER REMOVING AND REPLACING THE ENDOSCOPE AGAIN, THE SAME THING WAS OCCURRING. SURGEON ALSO TRIED TURNING THE SCOPE AND ROTATING IT AS WELL TO RESOLVE BUT, NOT EFFECTIVE. THE IMAGE WAS INVERTED. THE EVENT DID NOT CAUSE REVERSE CONTROL. THE ENDOSCOPE WAS INSTALLED IN UPWARD ORIENTATION. THE SURGEON CONFIRMED DESIRED ORIENTATION WHEN ENDOSCOPE WAS INSTALLED. THE ENDOSCOPE WAS ATTACHED WITH THE BASE. PRIOR TO THE EVENT, THE ENDOSCOPE MANUALLY ROTATED 180 DEGREES. A NEW SCOPE WAS USED. THERE WAS NO PATIENT INJURY.
INTUITIVE SURGICAL, INC. (ISI) OBTAINED ADDITIONAL INFORMATION: THE ISSUES DID NOT OCCUR WITH A DIFFERENT ENDOSCOPE. THE SAME ENDOSCOPE WAS USED. THE ISSUE OCCURRED BEFORE WITH THE SAME ENDOSCOPE AND WAS NOT RETURNED BECAUSE THE ENDOSCOPE WAS NOT FLAGGED BY THE STERILE TECHNICIAN AND WAS TAKEN DOWN TO REPROCESSING TO BE STERILIZED. THE ENDOSCOPE WAS THEN RE-WRAPPED AND PLACED BACK INTO CIRCULATION.
INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED.
INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 30-DEGREE ENDOSCOPE PLUS FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND WAS PLACED THROUGH FRICTION TEST USING A SCREENING AID TO MANUALLY ROTATE THE ADAPTER TO DETECT FOR FRICTION. THE CAMERA INSTRUMENT ADAPTER DID NOT ROTATE PROPERLY AND/OR NOISES WERE HEARD DURING TESTING AND CONFIRMED AS BINDING. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE: THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH COSMETIC DAMAGE. DURING INSPECTION OF THE ENDOSCOPE CABLE INTEGRATED CONNECTOR, THE CAB INTEGRATED CONNECTOR HOUSING EXHIBITED DISCOLORATION. VISUAL INSPECTION CONFIRMED. THE ENDOSCOPE WAS VISUALLY INSPECTED AND FOUND WITH MINOR CUT(S) TO THE CABLE INSULATION. THE DAMAGE WAS LOCATED AT ZONE C NEAR THE ENDOSCOPE HOUSING. THE ENDOSCOPE WAS TESTED AND PLACED ON A CAMERA ATTENUATION TESTER OR EQUIVALENT TO MEASURE TRANSMITTANCE BUT FAILED FUNCTIONAL TESTING. THE ENDOSCOPE FAILED TRANSMITTANCE DUE TO THE MEASURED OUTPUT POWER NOT MEETING SPECIFICATION LIMITS. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF THIS BINDING IS ATTRIBUTED TO COMPONENT SUSCEPTIBILITY TO INCREASED FRICTION.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE PLUS HAD THE VIEW BACKWARDS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.
REFER TO H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439975 | NONE | ENDOSCOPE PLUS | NAY | INTUITIVE SURGICAL, INC | 470057-11 | N/A | 00886874116555 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES. |