Definition: Alternative Mode Of Visualization Using Narrow Bands From The Visible Spectrum For Illumination And Indicated For Endoscopy And Endoscopic Surgery Of The Upper And Lower Diagestive Tract And Urinary Tract.
| Device Type ID | 2048 |
| Device Name | Endoscope, Accessories, Narrow Band Spectrum |
| Physical State | The System Consists Of Flexible And/or Ridgid Scope(s), Light Source(s), Video Processor And Display |
| Technical Method | Enhances Visualization Of Specific Structures And Reduces Obscuring Effects By Using Narrow Bands Of The Visible Spectrum For Illumination. Narrow Band Illumination Is Accomplished Through The Modification Of Broadband Light Sources With Optical Filt |
| Target Area | Limited To Endoscopic Systems For Observation Of The Gastro-urological Tract |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NWB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2048 |
| Device | Endoscope, Accessories, Narrow Band Spectrum |
| Product Code | NWB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OLYMPUS CORPORATION OF THE AMERICAS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SONOSCAPE MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Endoscope | 48 |
Adverse Event Without Identified Device Or Use Problem | 46 |
Microbial Contamination Of Device | 46 |
Insufficient Information | 20 |
Appropriate Term/Code Not Available | 16 |
Break | 15 |
Contamination / Decontamination Problem | 13 |
No Display / Image | 11 |
Device Operates Differently Than Expected | 9 |
Device Reprocessing Problem | 8 |
Erratic Or Intermittent Display | 6 |
Device Contamination With Chemical Or Other Material | 5 |
Material Deformation | 5 |
Difficult To Remove | 5 |
Electro-Static Discharge | 4 |
Device Contamination With Biological Material | 4 |
Material Fragmentation | 4 |
Detachment Of Device Component | 3 |
Mechanical Problem | 3 |
No Device Output | 3 |
Contamination During Use | 3 |
Tip | 3 |
No Apparent Adverse Event | 3 |
Maintenance Does Not Comply To Manufacturers Recommendations | 2 |
Residue After Decontamination | 2 |
Detachment Of Device Or Device Component | 2 |
Display Or Visual Feedback Problem | 2 |
Loose Or Intermittent Connection | 2 |
Leak / Splash | 2 |
Device Damaged By Another Device | 2 |
Material Protrusion / Extrusion | 2 |
False Device Output | 1 |
Excess Flow Or Over-Infusion | 1 |
Material Too Rigid Or Stiff | 1 |
Component Or Accessory Incompatibility | 1 |
Poor Quality Image | 1 |
Adhesive | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Entrapment Of Device | 1 |
Difficult To Insert | 1 |
Kinked | 1 |
Output Problem | 1 |
Noise, Audible | 1 |
Difficult To Position | 1 |
Collapse | 1 |
Increase In Pressure | 1 |
Connection Problem | 1 |
Fail-Safe Problem | 1 |
Degraded | 1 |
Obstruction Of Flow | 1 |
Deformation Due To Compressive Stress | 1 |
Inadequate Lighting | 1 |
Improper Device Output | 1 |
Power Problem | 1 |
Material Disintegration | 1 |
| Total Device Problems | 323 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Olympus Corporation Of The Americas | II | Mar-12-2019 |
| 2 | Olympus Corporation Of The Americas | II | Feb-24-2017 |