| Device Type ID | 4122 |
| Device Name | Device, Thermal Ablation, Endometrial |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MNB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4122 |
| Device | Device, Thermal Ablation, Endometrial |
| Product Code | MNB |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 301 |
Fluid Leak | 73 |
Device Handling Problem | 25 |
Insufficient Information | 18 |
Break | 18 |
Device Alarm System | 16 |
Device Operates Differently Than Expected | 14 |
Device Contamination With Chemical Or Other Material | 8 |
Burst Container Or Vessel | 7 |
Smoking | 6 |
Electrical /Electronic Property Problem | 5 |
Retraction Problem | 4 |
Hole In Material | 4 |
Detachment Of Device Component | 3 |
Leak / Splash | 3 |
Appropriate Term/Code Not Available | 3 |
Device Displays Incorrect Message | 3 |
Material Integrity Problem | 3 |
No Apparent Adverse Event | 2 |
Material Puncture / Hole | 2 |
Adapter (Adaptor) | 2 |
Balloon Leak(s) | 2 |
Crack | 1 |
Defective Device | 1 |
Calibration Problem | 1 |
Calibration Error | 1 |
Loose Or Intermittent Connection | 1 |
Malfunction | 1 |
Decrease In Pressure | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Material Deformation | 1 |
Unsealed Device Packaging | 1 |
Positioning Failure | 1 |
Electrode | 1 |
Use Of Device Problem | 1 |
Delivered As Unsterile Product | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Bent | 1 |
Device Operational Issue | 1 |
Human-Device Interface Problem | 1 |
| Total Device Problems | 540 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hologic, Inc | II | Feb-26-2014 |