| Device Type ID | 5927 |
| Device Name | Instrument, Ultrasonic Surgical |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LFL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5927 |
| Device | Instrument, Ultrasonic Surgical |
| Product Code | LFL |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COVIDIEN LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ENDOPRIME INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ETHICON ENDO-SURGERY, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INTEGRA | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
INTEGRA LIFESCIENCES CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA LIFESCIENCES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SRA DEVELOPMENTS, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 1598 |
Tip | 503 |
Probe | 426 |
Detachment Of Device Component | 426 |
Pad | 322 |
Inability To Irrigate | 232 |
Knife | 192 |
Detachment Of Device Or Device Component | 169 |
Fracture | 145 |
Component Falling | 126 |
Overheating Of Device | 110 |
Device Displays Incorrect Message | 93 |
Device Operates Differently Than Expected | 88 |
Adverse Event Without Identified Device Or Use Problem | 77 |
Device Stops Intermittently | 70 |
Failure To Cut | 54 |
Material Fragmentation | 54 |
Failure To Fire | 49 |
Insufficient Information | 35 |
Mechanical Problem | 27 |
Defective Device | 26 |
Insulation | 25 |
Melted | 25 |
Intermittent Energy Output | 22 |
Device Contamination With Chemical Or Other Material | 22 |
Component Missing | 20 |
Jaw | 20 |
Device Inoperable | 20 |
Noise, Audible | 19 |
Failure To Power Up | 16 |
Output Problem | 15 |
Difficult To Open Or Close | 15 |
Self-Activation Or Keying | 13 |
Temperature Problem | 12 |
Waveguide | 12 |
Peeled / Delaminated | 10 |
Material Separation | 10 |
Device Damaged Prior To Use | 10 |
Contamination / Decontamination Problem | 10 |
Failure To Adhere Or Bond | 10 |
Thermal Decomposition Of Device | 9 |
Failure To Deliver Energy | 9 |
Loose Or Intermittent Connection | 8 |
Crack | 8 |
Switch, Push Button | 7 |
Difficult Or Delayed Activation | 7 |
Material Deformation | 7 |
Material Integrity Problem | 7 |
Handpiece | 7 |
Use Of Device Problem | 7 |
Device Difficult To Setup Or Prepare | 6 |
Loss Of Or Failure To Bond | 6 |
Electronic Property Issue | 6 |
Device Contaminated During Manufacture Or Shipping | 6 |
Loss Of Power | 6 |
Device Alarm System | 6 |
Manufacturing, Packaging Or Shipping Problem | 5 |
Device Emits Odor | 5 |
Mechanical Jam | 5 |
Sticking | 5 |
Defective Component | 5 |
Product Quality Problem | 5 |
Power Problem | 5 |
Tear, Rip Or Hole In Device Packaging | 5 |
Human-Device Interface Problem | 5 |
Energy Output To Patient Tissue Incorrect | 4 |
Vibration | 4 |
Electrical /Electronic Property Problem | 4 |
Material Torqued | 4 |
Device Handling Problem | 4 |
Hole In Material | 4 |
Dull, Blunt | 4 |
Failure To Align | 4 |
Packaging Problem | 4 |
Failure To Shut Off | 4 |
Split | 3 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 3 |
Fluid Leak | 3 |
Leak / Splash | 3 |
Device Subassembly | 3 |
Delivered As Unsterile Product | 3 |
Suction Problem | 3 |
Unknown (for Use When The Device Problem Is Not Known) | 3 |
Appropriate Term/Code Not Available | 3 |
Smoking | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Pin | 3 |
Energy Output Problem | 3 |
Device Operational Issue | 3 |
Material Twisted / Bent | 2 |
Wheelchair, Wheels | 2 |
Fire | 2 |
Bent | 2 |
Burst Container Or Vessel | 2 |
Flare Or Flash | 2 |
Material Discolored | 2 |
Failure To Advance | 2 |
Device Dislodged Or Dislocated | 2 |
Deformation Due To Compressive Stress | 2 |
Material Puncture / Hole | 2 |
| Total Device Problems | 5389 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ethicon Endo-Surgery Inc | II | Jun-01-2018 |
| 2 | Ethicon Endo-Surgery Inc | II | Nov-16-2015 |
| 3 | Integra LifeSciences Corp. | II | Feb-23-2018 |
| 4 | Integra LifeSciences Corp. | II | Dec-01-2014 |
| 5 | Integra LifeSciences Corp. | II | Apr-29-2014 |
| 6 | Stryker Instruments Div. Of Stryker Corporation | II | Apr-13-2016 |
| 7 | Stryker Instruments Div. Of Stryker Corporation | II | Aug-07-2014 |
| 8 | Tenex Health Inc | II | May-06-2014 |