Definition: To Examine The Duodenum And To Perform Various Procedures Within The Duodenum. 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,
| Device Type ID | 1775 |
| Device Name | Duodenoscope And Accessories, Flexible/rigid |
| Physical State | Endoscope, Accessories Associated With Duodenoscope |
| Technical Method | Inserted Orally Into Duodenum |
| Target Area | Duodenum, Esophagus |
| 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 | FDT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1775 |
| Device | Duodenoscope And Accessories, Flexible/rigid |
| Product Code | FDT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FUJIFILM CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
HOYA CORPORATION PENTAX DIVISION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PENTAX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Loss Of Or Failure To Bond | 798 |
Microbial Contamination Of Device | 479 |
Adverse Event Without Identified Device Or Use Problem | 208 |
Endoscope | 137 |
Device Reprocessing Problem | 110 |
Contamination During Use | 48 |
Break | 44 |
Appropriate Term/Code Not Available | 32 |
Corroded | 19 |
Insufficient Information | 19 |
Contamination / Decontamination Problem | 15 |
Device Issue | 9 |
Design/structure Problem | 5 |
No Display / Image | 5 |
Separation Failure | 4 |
Device Contamination With Biological Material | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Mechanical Problem | 4 |
Collapse | 3 |
Positioning Failure | 3 |
Material Puncture / Hole | 3 |
Obstruction Of Flow | 2 |
Material Frayed | 2 |
Failure To Disinfect | 2 |
Spring | 2 |
Complete Blockage | 2 |
Crack | 2 |
Missing Value Reason | 1 |
Separation Problem | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Difficult To Advance | 1 |
Material Too Rigid Or Stiff | 1 |
Misassembly By Users | 1 |
Failure To Clean Adequately | 1 |
Detachment Of Device Component | 1 |
Device Maintenance Issue | 1 |
Poor Quality Image | 1 |
Unintended System Motion | 1 |
Device Displays Incorrect Message | 1 |
Deformation Due To Compressive Stress | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Tip | 1 |
No Apparent Adverse Event | 1 |
Use Of Device Problem | 1 |
Image Resolution Poor | 1 |
Defective Component | 1 |
Material Integrity Problem | 1 |
Difficult To Remove | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 1987 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Fujifilm Medical Systems U.S.A., Inc. | II | Sep-27-2017 |
| 2 | Fujifilm Medical Systems U.S.A., Inc. | II | Sep-13-2017 |
| 3 | Fujifilm Medical Systems U.S.A., Inc. | II | May-31-2016 |
| 4 | Fujifilm Medical Systems U.S.A., Inc. | II | Dec-15-2015 |
| 5 | Fujifilm Medical Systems U.S.A., Inc. | II | Sep-17-2015 |
| 6 | Olympus America Inc. | II | Sep-22-2015 |
| 7 | Olympus Corporation Of The Americas | II | May-31-2016 |
| 8 | Olympus Corporation Of The Americas | II | Feb-04-2016 |
| 9 | Pentax Medical Company | II | Jul-23-2016 |
| 10 | Pentax Medical Company | II | May-27-2016 |
| 11 | Pentax Of America Inc | II | Feb-20-2018 |
| 12 | Pentax Of America Inc | II | Jul-11-2017 |