FDA Adverse Event
Injury
Summary report: N
NOVASURE IMPEDANCE CONTROLLED EA SYSTEM
MDR report key: 3925624
·
Received June 27, 2014
Report
- Report Number
- 1222780-2014-00103
- Event Type
- Injury
- Date Received
- June 27, 2014
- Date of Event
- May 30, 2014
- Report Date
- May 30, 2014
- Manufacturer
- HOLOGIC
- Product Code
- MNB
- PMA / PMN Number
- P010013
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IDENTIFIED LOT NUMBER AND SERIAL NUMBER OF THE DISPOSABLE DEVICE. NO ABNORMALITIES WERE FOUND RELATED TO THE REPORTED INFO. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED A PHYSICIAN COMPLETED A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2014. POST PROCEDURE THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND VISUALIZED A "PERFORATION AT THE TOP OF THE FUNDUS". NO INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 376598 | NOVASURE IMPEDANCE CONTROLLED EA SYSTEM | UTERINE ABLATION DEVICE | MNB | HOLOGIC | NS2000 | 14A30RB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK |