FDA Adverse Event
Malfunction
Summary report: N
8MM MCS TIP COVER ACCESSORY
MDR report key: 1230427
·
Received November 7, 2008
Report
- Report Number
- 2955842-2008-01353
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 13, 2008
- Report Date
- November 7, 2008
- Manufacturer
- INTUITIVE SURGICAL, INC.
- Product Code
- NAY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS- 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 INFO IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, "A PIN HOLE DEVELOPED" IN THE TIP COVER ACCESSORY INSTALLED ON THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT. THE PT EXPERIENCED A VESSEL INJURY. NO OTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8MM MCS TIP COVER ACCESSORY | ELECTROSURGICAL INSTRUMENT ACCESSORY | NAY | INTUITIVE SURGICAL, INC. | 400180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other | DA VINCI S SURGICAL SYSTEM| ELECTROSURGICAL UNIT| MONOPOLAR CURVED SCISSORS INSTRUMENT |