Definition: If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 FR 26807, Available At Https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
| Device Type ID | 2522 |
| Device Name | Accessories, Cleaning, For Endoscope |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FEB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2522 |
| Device | Accessories, Cleaning, For Endoscope |
| Product Code | FEB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED STERILIZATION PRODUCTS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CUSTOM ULTRASONICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 79 |
Microbial Contamination Of Device | 72 |
Device Reprocessing Problem | 49 |
Improper Or Incorrect Procedure Or Method | 32 |
Off-Label Use | 21 |
Appropriate Term/Code Not Available | 15 |
Fumes Or Vapors | 14 |
Maintenance Does Not Comply To Manufacturers Recommendations | 12 |
Contamination / Decontamination Problem | 12 |
Break | 10 |
Use Of Incorrect Control Settings | 9 |
Chemical Spillage | 9 |
Leak / Splash | 8 |
Chemical Problem | 8 |
Use Of Device Problem | 8 |
Mechanical Problem | 7 |
Fluid Leak | 6 |
Device Contamination With Chemical Or Other Material | 6 |
Endoscope | 6 |
Device Component Or Accessory | 6 |
Contamination During Use | 5 |
Facilities Issue | 5 |
Device Handling Problem | 5 |
Failure To Disinfect | 4 |
Failure To Clean Adequately | 4 |
Human-Device Interface Problem | 4 |
Ventilation Problem In Device Environment | 4 |
Connection Problem | 3 |
Bacterial Filter | 3 |
No Apparent Adverse Event | 3 |
Inadequate Filtration Process | 3 |
Collapse | 3 |
Component Falling | 3 |
Sensor | 2 |
Flushing Problem | 2 |
Filter | 2 |
Endoscopic Accessory | 2 |
Device Contamination With Biological Material | 2 |
Electrical Shorting | 2 |
Shipping Damage Or Problem | 2 |
Residue After Decontamination | 2 |
Water Purification System | 2 |
Misconnection | 2 |
Data Problem | 1 |
Test Strip | 1 |
Display Difficult To Read | 1 |
Loss Of Data | 1 |
Unintended Electrical Shock | 1 |
Device Displays Incorrect Message | 1 |
Function Lid | 1 |
Material Frayed | 1 |
Unintended System Motion | 1 |
Inadequate Service | 1 |
No Flow | 1 |
Power Supply | 1 |
Reservoir | 1 |
No Display / Image | 1 |
Pressure Problem | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Accessory Incompatible | 1 |
Detachment Of Device Component | 1 |
Device Emits Odor | 1 |
Environmental Compatibility Problem | 1 |
Component Incompatible | 1 |
Separation Problem | 1 |
Blocked Connection | 1 |
Crack | 1 |
Device Rinsing Issue | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Device Unsafe To Use In Environment | 1 |
Mechanics Altered | 1 |
Temperature Sensor | 1 |
Misassembly During Maintenance / Repair | 1 |
| Total Device Problems | 489 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Advanced Sterilization Products | II | Jan-09-2017 |
| 2 | Advanced Sterilization Products | II | Jun-05-2015 |
| 3 | Olympus Corporation Of The Americas | II | Oct-19-2016 |