FDA Adverse Event
Malfunction
Summary report: N
MONOPOLAR CURVED SCISSORS INSTRUMENT
MDR report key: 1230428
·
Received November 7, 2008
Report
- Report Number
- 2955842-2008-01354
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 14, 2008
- Report Date
- November 7, 2008
- Manufacturer
- INTUITIVE SURGICAL, INC.
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- 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 INFO IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT NEAR THE END OF A DA VINCI S HYSTERECTOMY PROCEDURE, AFTER THE UTERUS WAS REMOVED, THE SURGEON NOTICE ARCING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH A MCS TIP COVER ACCESSORY INSTALLED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH THE ORIGINAL MCS INSTRUMENT AND TIP COVER. NO PT HARM ADVERSE OUTCOME OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MONOPOLAR CURVED SCISSORS INSTRUMENT | ELECTROSURGICAL INSTRUMENT | GEI | INTUITIVE SURGICAL, INC. | 420179-08 | 0805021 808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | DA VINCI S SURGICAL SYSTEM| TIP COVER ACCESSORY| ELECTROSURGICAL UNIT |