| Device Type ID | 2588 |
| Device Name | Lavage, Jet |
| Regulation Description | Jet Lavage. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5475 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FQH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2588 |
| Device | Lavage, Jet |
| Product Code | FQH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Jet Lavage. |
| CFR Regulation Number | 880.5475 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NEXT SCIENCE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMITH & NEPHEW, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Biocompatibility | 67 |
Expulsion | 65 |
Device Contaminated During Manufacture Or Shipping | 61 |
Overheating Of Device | 49 |
Leak / Splash | 48 |
Break | 32 |
Battery Problem | 30 |
Fluid Leak | 29 |
Device Contamination With Chemical Or Other Material | 23 |
Appropriate Term/Code Not Available | 21 |
Smoking | 20 |
Detachment Of Device Or Device Component | 17 |
Difficult To Insert | 17 |
Disassembly | 15 |
Corroded | 14 |
Fracture | 13 |
Mechanical Problem | 13 |
Device Operates Differently Than Expected | 12 |
Adverse Event Without Identified Device Or Use Problem | 12 |
Melted | 10 |
Electrical /Electronic Property Problem | 8 |
Delivered As Unsterile Product | 7 |
Electrical Power Problem | 7 |
Inaccurate Delivery | 7 |
Temperature Problem | 7 |
Defective Device | 6 |
Material Deformation | 6 |
Failure To Power Up | 6 |
Insufficient Information | 5 |
Defective Component | 5 |
Burst Container Or Vessel | 4 |
Use Of Device Problem | 4 |
Noise, Audible | 4 |
Device Emits Odor | 4 |
Detachment Of Device Component | 3 |
Decrease In Pressure | 3 |
Disconnection | 3 |
Inability To Irrigate | 2 |
Material Rupture | 2 |
Packaging Problem | 2 |
Pumping Stopped | 2 |
Suction Problem | 2 |
Device Dislodged Or Dislocated | 2 |
Connection Problem | 2 |
Difficult To Remove | 2 |
Battery | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Handpiece | 2 |
Power Conditioning Problem | 1 |
Device Stops Intermittently | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Improper Device Output | 1 |
Power Problem | 1 |
Sparking | 1 |
Device Reprocessing Problem | 1 |
Material Disintegration | 1 |
Device, Or Device Fragments Remain In Patient | 1 |
Premature Discharge Of Battery | 1 |
Circuit Failure | 1 |
Increase In Pressure | 1 |
Contamination / Decontamination Problem | 1 |
Explosion | 1 |
No Flow | 1 |
No Apparent Adverse Event | 1 |
Failure To Charge | 1 |
Obstruction Of Flow | 1 |
Particulates | 1 |
Shipping Damage Or Problem | 1 |
Blocked Connection | 1 |
No Device Output | 1 |
Charred | 1 |
Improper Flow Or Infusion | 1 |
Battery Problem: Low Impedance | 1 |
Scratched Material | 1 |
Loose Or Intermittent Connection | 1 |
Moisture Damage | 1 |
Restricted Flow Rate | 1 |
Device Alarm System | 1 |
Thermal Decomposition Of Device | 1 |
Chemical Spillage | 1 |
No Pressure | 1 |
Pressure Problem | 1 |
Excessive Heating | 1 |
Unsealed Device Packaging | 1 |
Loss Of Power | 1 |
Off-Label Use | 1 |
Device Packaging Compromised | 1 |
Mechanical Jam | 1 |
| Total Device Problems | 719 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 2 | Maquet Cardiovascular, LLC | II | Mar-07-2019 |
| 3 | Medex Cardio-Pulmonary Inc., D.b.a. Smiths Medical Company | II | Nov-20-2018 |
| 4 | Stryker Instruments Div. Of Stryker Corporation | II | Mar-28-2018 |
| 5 | Stryker Instruments Div. Of Stryker Corporation | II | Jul-13-2015 |