FDA Adverse Event
Malfunction
Summary report: N
NOVASURE
MDR report key: 1349753
·
Received March 12, 2009
Report
- Report Number
- 1349753
- Event Type
- Malfunction
- Date Received
- March 12, 2009
- Date of Event
- January 23, 2009
- Report Date
- March 12, 2009
- Manufacturer
- CYTYC SURGICAL SERVICES, INC.
- Product Code
- MKN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
Narratives
Description of Event or Problem · 1
NOVASURE DEVICE WAS INSERTED INTO THE UTERINE CAVITY, BUT CAVITY INTEGRITY TASK COULD NOT BE PASSED; DESPITE ADDITION OF AGENTS TO OCCLUDE THE CERVICAL CANAL AT THE OS, AND APPLICATION OF ADDITIONAL TENACULUM. A SECOND NOVASURE ARRAY FUNCTIONED NORMALLY. CAVITY INTEGRITY TEST WAS PASSED, AND THE ABLATION WAS CARRIED OUT WITHOUT DIFFICULTY.====================== MANUFACTURER RESPONSE FOR IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION DISPOSABLE DEVICE KIT, NOVASURE======================VENDOR REPRESENTATIVE PRESENT DURING CASE TO SUPPORT PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOVASURE | HANDPIECE, ABLATION, ENDOMETRIAL | MKN | CYTYC SURGICAL SERVICES, INC. | * | 08G03HA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |