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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device saw, powered, and accessories
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHAB
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2016 358 358
2017 1363 1363
2018 681 681
2019 676 676
2020 1462 1462
2021 1580 1580

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 2385 2385
Mechanical Jam 1611 1611
Temperature Problem 374 374
Protective Measures Problem 350 350
Electrical Shorting 152 152
Noise, Audible 141 141
Metal Shedding Debris 131 131
Break 127 127
Device Operates Differently Than Expected 125 125
Flaked 119 119
Device Inoperable 96 96
Mechanical Problem 73 73
Device Displays Incorrect Message 60 60
Material Fragmentation 59 59
Electrical /Electronic Property Problem 51 51
Insufficient Information 49 49
Physical Resistance/Sticking 42 42
Smoking 41 41
No Apparent Adverse Event 40 40
Communication or Transmission Problem 40 40
Material Separation 38 38
Failure to Power Up 36 36
Sticking 35 35
Self-Activation or Keying 33 33
Sparking 32 32
Appropriate Term/Code Not Available 32 32
Loss of Power 29 29
Connection Problem 29 29
Circuit Failure 27 27
Unintended Power Up 25 25
Melted 24 24
Detachment Of Device Component 23 23
Adverse Event Without Identified Device or Use Problem 22 22
Failure to Shut Off 18 18
Detachment of Device or Device Component 17 17
Corroded 17 17
Thermal Decomposition of Device 15 15
Material Deformation 13 13
Failure to Cut 13 13
Activation Problem 13 13
Fluid Leak 12 12
Material Disintegration 12 12
Device Markings/Labelling Problem 11 11
Device Remains Activated 10 10
Device Stops Intermittently 10 10
Peeled/Delaminated 9 9
Dull, Blunt 9 9
Device Emits Odor 9 9
Defective Device 9 9
Material Twisted/Bent 9 9
Therapeutic or Diagnostic Output Failure 9 9
Output Problem 8 8
Display or Visual Feedback Problem 8 8
Defective Component 8 8
Material Integrity Problem 8 8
Power Problem 8 8
Partial Blockage 8 8
Image Display Error/Artifact 7 7
Activation, Positioning or SeparationProblem 7 7
Component Missing 6 6
Loose or Intermittent Connection 6 6
Component Falling 6 6
Material Frayed 6 6
Unintended Movement 6 6
Positioning Problem 5 5
Device Contaminated During Manufacture or Shipping 5 5
Device Contamination with Chemical or Other Material 5 5
Material Discolored 5 5
Failure to Auto Stop 5 5
Failure to Cycle 4 4
Device Slipped 4 4
Unexpected Shutdown 4 4
Contamination /Decontamination Problem 4 4
Vibration 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Mechanics Altered 4 4
Device Fell 3 3
Failure to Advance 3 3
Electronic Property Issue 3 3
Device-Device Incompatibility 3 3
Leak/Splash 3 3
Intermittent Energy Output 3 3
Material Protrusion/Extrusion 3 3
Operating System Becomes Nonfunctional 3 3
Intermittent Loss of Power 3 3
Blocked Connection 3 3
Computer Operating System Problem 2 2
Device Dislodged or Dislocated 2 2
Naturally Worn 2 2
Use of Device Problem 2 2
Material Opacification 2 2
Hole In Material 2 2
Premature Activation 2 2
Unintended Ejection 2 2
Complete Blockage 2 2
Component Incompatible 2 2
Crack 2 2
Delivered as Unsterile Product 2 2
Occlusion Within Device 2 2
Energy Output Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2672 2672
No Clinical Signs, Symptoms or Conditions 1786 1786
No Patient Involvement 977 977
No Information 356 356
No Consequences Or Impact To Patient 223 223
Foreign Body In Patient 31 31
Insufficient Information 23 23
No Code Available 16 16
Burn(s) 15 15
Injury 11 11
Device Embedded In Tissue or Plaque 11 11
Partial thickness (Second Degree) Burn 5 5
Laceration(s) 4 4
Abrasion 3 3
Unspecified Infection 3 3
Test Result 3 3
Burn, Thermal 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Patient Problem/Medical Problem 2 2
Hemorrhage/Bleeding 2 2
Capsular Contracture 2 2
Pain 2 2
Loss of Range of Motion 1 1
Scar Tissue 1 1
Damage to Ligament(s) 1 1
Muscle Weakness 1 1
Forced Expiratory Volume Decreased 1 1
Post Operative Wound Infection 1 1
Fever 1 1
Adhesion(s) 1 1
Intracranial Hemorrhage 1 1
Failure of Implant 1 1
Inflammation 1 1
Fibrosis 1 1
Not Applicable 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Oct-30-2018
2 Smith & Nephew, Inc. II Feb-22-2017
3 Zimmer Biomet, Inc. II Oct-26-2016
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