FDA Adverse Event
Injury
Summary report: N
MCROWAVE ENDOMETERIAL ABLATION (MEA) SYSTEM
MDR report key: 1060907
·
Received June 13, 2008
Report
- Report Number
- 9710493-2008-00004
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 6, 2008
- Report Date
- June 16, 2008
- Manufacturer
- MICROSULIS MEDICAL LTD.
- Product Code
- MNB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MEA SYSTEM RECORDS DATA FOR EACH PATIENT TREATMENT PROCEDURE, INCLUDING SYSTEM PARAMETERS AND PATIENT DATA ENTERED BY THE PHYSICIAN. THE COMPANY ANALYZED THE MEA SYSTEM'S TREATMENT DATA FILE ASSOCIATED WITH THIS EVENT. THE CONCLUSION OF THE ANALYSIS WAS THAT THE MEA SYSTEM WAS FUNCTIONING WITHIN OPERATING SPECIFICATIONS AT THE TIME OF THE TREATMENT, AND NO MALFUNCTIONS OR PERFORMANCE DEVIATIONS WERE PRESENT.
Description of Event or Problem · 1
PATIENT WAS TREATED WITH A REUSABLE APPLICATOR AFTER 3 FAILED CAVITY INTEGRITY TESTS WITH NOVASURE. THE PATIENT WAS READMITTED 1 DAY POST MEA WITH COMPLAINT OF ABDOMINAL PAIN AND EMESIS. LAPAROTOMY REVEALED THERMAL INJURY TO THE UTERUS AND BOWEL. HYSTERECTOMY AND BOWEL RESECTION PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MCROWAVE ENDOMETERIAL ABLATION (MEA) SYSTEM | MICROWAVE ENDOMETRIAL ABLATION DEVICE | MNB | MICROSULIS MEDICAL LTD. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |