FDA Adverse Event
Other
Summary report: N
CANNULA SEAL ACCESSORY
MDR report key: 1071380
·
Received July 7, 2008
Report
- Report Number
- 2955842-2008-01132
- Event Type
- Other
- Date Received
- July 7, 2008
- Report Date
- July 7, 2008
- Manufacturer
- INTUITIVE SURGICAL, INC.
- Product Code
- GCJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CANNULA SEAL ACCESSORY WAS NOT RETURNED FOR EVAL. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFO BECOMES AVAILABLE A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON COMPLETION OF A DA VINCI S PROSTATECTOMY PROCEDURE, THE INNER, CLEAR SEAL WAS MISSING FROM THE CANNULA SEAL ACCESSORY. AN INSPECTION OF THE INSIDE OF THE PT WAS PERFORMED AND THE MISSING PORTION WAS NOT LOCATED. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CANNULA SEAL ACCESSORY | ENDOSCOPIC ACCESSORY | GCJ | INTUITIVE SURGICAL, INC. | 400077-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | DA VINCI S SURGICAL SYSTEM| INSTRUMENTS |