Definition: Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility
| Device Type ID | 2177 |
| Device Name | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Physical State | Synthetic Woven Or Non-woven Fabric Of Varying Material Properties (e.g., Density, Pore Size, Weave, Resorption, Etc.); Design Can Be Pre-configured Or Can Be A Sheet To Allow Surgeon To Cut Mesh To Desired Size And Shap |
| Technical Method | Placed Under The Urethra Transvaginally Using A Transobturator (one Vaginal Incision And Two Groin/upper Thigh Incisions) Or Retropubic (one Vaginal Incision And Two Abdominal Incisions) Approach; During Instances Of Increased Abdominal Pressure (e.g |
| Target Area | Urethra, Vagina |
| Regulation Description | Surgical Mesh. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OTN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2177 |
| Device | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Product Code | OTN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CALDERA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CALDERA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 2049 |
Migration Or Expulsion Of Device | 1931 |
Adverse Event Without Identified Device Or Use Problem | 1048 |
Insufficient Information | 932 |
Material Erosion | 235 |
Migration | 125 |
Extrusion | 86 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 57 |
Break | 30 |
Detachment Of Device Component | 21 |
No Apparent Adverse Event | 15 |
Difficult To Advance | 14 |
Torn Material | 13 |
Material Split, Cut Or Torn | 9 |
Patient-Device Incompatibility | 9 |
Detachment Of Device Or Device Component | 7 |
Material Deformation | 7 |
Hole In Material | 6 |
Material Separation | 6 |
Separation Failure | 6 |
Material Twisted / Bent | 6 |
Bent | 6 |
Material Frayed | 6 |
Surgical Graft | 5 |
Difficult To Remove | 5 |
Tear, Rip Or Hole In Device Packaging | 5 |
Device Packaging Compromised | 4 |
Unsealed Device Packaging | 4 |
Defective Device | 3 |
Needle | 3 |
Device Dislodged Or Dislocated | 3 |
Activation, Positioning Or Separation Problem | 2 |
Explanted | 2 |
Material Integrity Problem | 2 |
Device Operates Differently Than Expected | 2 |
Material Perforation | 2 |
Malposition Of Device | 2 |
Material Fragmentation | 2 |
Device Issue | 1 |
Material Protrusion / Extrusion | 1 |
Folded | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Device Markings / Labelling Problem | 1 |
Positioning Problem | 1 |
Difficult To Insert | 1 |
Kinked | 1 |
Loose Or Intermittent Connection | 1 |
Disconnection | 1 |
Cut In Material | 1 |
Split | 1 |
Difficult To Position | 1 |
Stretched | 1 |
Human-Device Interface Problem | 1 |
Osseointegration Problem | 1 |
Device Appears To Trigger Rejection | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
Delamination | 1 |
Degraded | 1 |
Difficult Or Delayed Positioning | 1 |
| Total Device Problems | 6693 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | American Medical Systems, Inc. | II | Dec-16-2014 |