FDA Adverse Event
Other
Summary report: N
DA VINCI SI SURGICAL SYSTEM
MDR report key: 2221088
·
Received August 23, 2011
Report
- Report Number
- 2955842-2011-00273
- Event Type
- Other
- Date Received
- August 23, 2011
- Date of Event
- July 24, 2011
- Report Date
- July 24, 2011
- Manufacturer
- INTUITIVE SURGICAL,INC.
- Product Code
- NAY
- PMA / PMN Number
- K081137
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INVESTIGATION CONDUCTED BY AN ISI REPRESENTATIVE CONCLUDED THAT SYSTEM WAS WORKING AS INTENDED WITH NO REPORTED OR OBSERVED MALFUNCTIONS. THE SURGEON IS AWARE OF THE USER RELATED ACTIONS THAT CONTRIBUTED TO THIS EVENT AND ON (B)(4) 2011, ADDITIONAL TRAINING WAS CONDUCTED WITH THE SURGEON. AS OF (B)(4) 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT AT THE END OF A DA VINCI SI GALL BLADDER PROCEDURE, THE SURGEON INADVERTENTLY PUNCTURED THE PATIENT'S LIVER. REPAIR WAS PERFORMED USING CAUTERIZATION AND A COAGULATING GEL. NO ADDITIONAL PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DA VINCI SI SURGICAL SYSTEM | ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | NAY | INTUITIVE SURGICAL,INC. | IS3000 A6.0P5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES |