FDA Adverse Event
Injury
Summary report: N
DA VINCI S SURGICAL SYSTEM
MDR report key: 2193069
·
Received August 5, 2011
Report
- Report Number
- 2955842-2011-00259
- Event Type
- Injury
- Date Received
- August 5, 2011
- Date of Event
- January 18, 2011
- Report Date
- January 21, 2013
- Manufacturer
- INTUITIVE SURGICAL,INC.
- Product Code
- NAY
- PMA / PMN Number
- K011002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ON (B)(4) 2011, (B)(4) HOSPITAL (B)(4), STATED THAT THE PATIENT INJURY WAS NOT BELIEVED TO BE A RESULT OF A DA VINCI S SYSTEM MALFUNCTION. INTUITIVE SURGICAL HAS MADE MULTIPLE ATTEMPTS TO OBTAIN DETAILED INFORMATION CONCERNING THE PATIENT, THEIR DIAGNOSIS, PRE-EXISTING MEDICAL CONDITIONS AND / OR ANY OTHER RELATED ADDITIONAL INFORMATION. HOWEVER, ON (B)(4) 2011, (B)(4), STATED THAT SHE IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION ABOUT THIS CASE.
Description of Event or Problem · 1
ON (B)(6) 2011 (B)(4) REPORTED THAT POST A DA VINCI S HYSTERECTOMY PROCEDURE, WHICH TOOK PLACE ON (B)(6) 2011, THE PATIENT RETURNED TO THE HOSPITAL WITH COMPLICATIONS AND WAS FOUND TO HAVE A BOWEL PERFORATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DA VINCI S SURGICAL SYSTEM | ENDOSCOPIC INSTRUMENT CONTROL SYSTEM | NAY | INTUITIVE SURGICAL,INC. | IS2000 A5.1P8 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES |