FDA Adverse Event
Malfunction
Summary report: N
8MM MCS TIP COVER ACCESSORY
MDR report key: 1230439
·
Received November 7, 2008
Report
- Report Number
- 2955842-2008-01357
- Event Type
- Malfunction
- Date Received
- November 7, 2008
- Date of Event
- October 16, 2008
- Report Date
- November 7, 2008
- Manufacturer
- INTUITIVE SURGICAL, INC.
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
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 DURING A DA VINCI SACROCOLPOPEXY WITH HYSTERECTOMY PROCEDURE, THE SURGEON NOTICED ARCING FROM THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WITH A MCS TIP COVER ACCESSORY INSTALLED. NO OTHER INFO WAS PROVIDED. NO PT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8MM MCS TIP COVER ACCESSORY | ELECTROSURGICAL INSTRUMENT ACCESSORY | GEI | INTUITIVE SURGICAL, INC. | 400180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MONOPOLAR CURVED SCISSORS INSTRUMENT| ELECTROSURGICAL UNIT| DA VINCI S SURGICAL SYSTEM |