| Device Type ID | 1936 |
| Device Name | Endoscope, Ac-powered And Accessories |
| 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 | GCP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1936 |
| Device | Endoscope, Ac-powered And Accessories |
| Product Code | GCP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Break | 75 |
Product Quality Problem | 23 |
Electrode | 21 |
Tip | 13 |
Mechanical Problem | 10 |
Fracture | 9 |
Material Fragmentation | 8 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Sparking | 2 |
Detachment Of Device Component | 2 |
Device Or Device Fragments Location Unknown | 2 |
Charred | 1 |
Hinge | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Adhesive | 1 |
Ball | 1 |
Mechanical Jam | 1 |
Device Handling Problem | 1 |
Unclear Information | 1 |
Communication Or Transmission Problem | 1 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
Difficult To Remove | 1 |
Lock | 1 |
Wire | 1 |
Failure To Transmit Record | 1 |
No Apparent Adverse Event | 1 |
Endoscope | 1 |
Component Missing | 1 |
Difficult To Open Or Close | 1 |
| Total Device Problems | 187 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Olympus Corporation Of The Americas | II | Feb-23-2018 |
| 2 | Olympus Corporation Of The Americas | II | Jun-26-2017 |