FDA Adverse Event
Malfunction
Summary report: N
8MM MCS TIP COVER ACCESSORY
MDR report key: 2220922
·
Received August 23, 2011
Report
- Report Number
- 2955842-2011-00272
- Event Type
- Malfunction
- Date Received
- August 23, 2011
- Date of Event
- July 25, 2011
- Report Date
- July 25, 2011
- Manufacturer
- INTUITIVE SURGICAL,INC.
- Product Code
- NAY
- PMA / PMN Number
- K050005
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TIP COVER ACCESSORY AND MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAVE NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A DA VINCI SI NEPHRECTOMY PROCEDURE, WHILE DISSECTING THE PATIENT'S KIDNEY, ARCING WAS OBSERVED COMING FROM THE TIP COVER ACCESSORY INSTALLED ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE TIP COVER ACCESSORY WAS REMOVED AND A HOLE WAS FOUND. THE TIP COVER ACCESSORY WAS REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8MM MCS TIP COVER ACCESSORY | ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY | NAY | INTUITIVE SURGICAL,INC. | 400180-10 | C11057 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES & ES |