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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device scalpel, ultrasonic, reprocessed
Definition The ultrasonic scalpel is intended for incision and excision of soft tissues. This device is indicated for reuse/reprocessing.
Product CodeNLQ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
STERILMED
  SUBSTANTIALLY EQUIVALENT 3
STERILMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 93 93
2016 72 72
2017 87 87
2018 56 56
2019 45 45
2020 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 69 69
Break 68 68
Detachment Of Device Component 34 34
Device Inoperable 28 28
Device Operates Differently Than Expected 27 27
Tip 26 26
Loss of Power 21 21
Detachment of Device or Device Component 20 20
Energy Output To Patient Tissue Incorrect 16 16
Component Falling 15 15
Melted 14 14
Pad 12 12
Use of Device Problem 11 11
Failure to Cut 10 10
Energy Output Problem 9 9
Handpiece 9 9
Device Stops Intermittently 8 8
Material Separation 7 7
Jaw 7 7
Thermal Decomposition of Device 7 7
Noise, Audible 7 7
Loose or Intermittent Connection 6 6
Difficult to Open or Close 6 6
Material Fragmentation 5 5
Smoking 5 5
Mechanical Problem 5 5
Overheating of Device 5 5
Device Remains Activated 5 5
False Alarm 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Appropriate Term/Code Not Available 4 4
Physical Resistance/Sticking 3 3
Device Fell 3 3
Switch, Push Button 3 3
Insufficient Information 3 3
Mechanics Altered 3 3
Therapeutic or Diagnostic Output Failure 3 3
Defective Device 3 3
Sparking 3 3
Failure to Sense 3 3
Entrapment of Device 3 3
Failure To Adhere Or Bond 3 3
Device Alarm System 2 2
Cord 2 2
Charred 2 2
Continuous Firing 2 2
Failure to Power Up 2 2
Fracture 2 2
Defective Component 2 2
Device Dislodged or Dislocated 2 2
Pressure Problem 2 2
Failure of Device to Self-Test 2 2
Device Subassembly 2 2
Split 2 2
Adhesive 2 2
Audible Prompt/Feedback Problem 1 1
Activation Problem 1 1
Naturally Worn 1 1
Failure to Shut Off 1 1
Inappropriate or Unexpected Reset 1 1
Mechanical Jam 1 1
Reset Problem 1 1
Temperature Problem 1 1
Environmental Particulates 1 1
Device Operational Issue 1 1
Device Sensing Problem 1 1
Device Or Device Fragments Location Unknown 1 1
Device Ingredient or Reagent Problem 1 1
Component Missing 1 1
Metal Shedding Debris 1 1
Sticking 1 1
Application Program Problem 1 1
Battery Problem 1 1
Deformation Due to Compressive Stress 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Activation, Positioning or SeparationProblem 1 1
Peeled/Delaminated 1 1
Premature Elective Replacement Indicator 1 1
Device Difficult to Setup or Prepare 1 1
Failure to Read Input Signal 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Generator 1 1
Spring 1 1
Seal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 177 177
No Consequences Or Impact To Patient 124 124
Blood Loss 23 23
No Information 21 21
Foreign Body In Patient 9 9
Hemorrhage/Bleeding 9 9
No Patient Involvement 4 4
No Code Available 3 3
Device Embedded In Tissue or Plaque 2 2
Burn(s) 2 2
Death 2 2
Dyspnea 1 1
Hematoma 1 1
Cardiac Arrest 1 1
High Blood Pressure/ Hypertension 1 1
Unspecified Infection 1 1
Swelling 1 1
Tissue Damage 1 1
Abscess 1 1
Brain Injury 1 1
Injury 1 1
Respiratory Failure 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Sustainability Solutions II Jul-18-2018
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