FDA Adverse Event
Injury
Summary report: N
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
MDR report key: 920619
·
Received September 26, 2007
Report
- Report Number
- 1222780-2007-00028
- Event Type
- Injury
- Date Received
- September 26, 2007
- Date of Event
- August 24, 2007
- Report Date
- August 28, 2007
- Manufacturer
- CYTYC SURGICAL PRODUCTS
- Product Code
- MNB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED TO CYTYC SURGICAL PRODUCTS, THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED. BECAUSE THE LOT NUMBER WAS NOT PROVIDED, AN INVESTIGATION OR REVIEW OF THE DEVICE HISTORY RECORD FOR THE DEVICE WAS NOT ABLE TO BE PERFORMED. NO FURTHER INFORMATION COULD BE OBTAINED THUS NO CONCLUSION CAN BE DRAWN FOR THIS EVENT.
Description of Event or Problem · 1
USER FACILITY REPORTED THE DAY FOLLOWING AN UNEVENTFUL UTERINE ABLATION USING THE NOVASURE SYSTEM, THE PATIENT COMPLAINED OF FEVER AND WAS ADMITTED. ANTIBIOTIC TREATMENT WAS GIVEN FOR POSITIVE VAGINAL CULTURES (GROUP B STREPTOCOCCUS). BLOOD CULTURES WERE NEGATIVE. THE PATIENT WAS DISCHARGED WITHIN 48 HOURS WITH NO FURTHER SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOVASURE IMPEDANCE CONTROLLED EA SYSTEM | RADIO FREQUENCY ENDOMETRIAL ABLATION | MNB | CYTYC SURGICAL PRODUCTS | NS2000 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Hospitalization| R |