Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device instrument, surgical, orthopedic, ac-powered motor and accessory/attachment
Product CodeHWE
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 3452 4249
2020 3248 4035
2021 3140 3843
2022 3327 4019
2023 3399 4241
2024 1495 2050

Device Problems MDRs with this Device Problem Events in those MDRs
Physical Resistance/Sticking 3393 3473
Mechanical Jam 2681 2681
Complete Loss of Power 2571 2571
Output below Specifications 1609 1609
Fracture 1553 2169
Break 1341 1371
Excessive Heating 1338 1338
Noise, Audible 979 979
Detachment of Device or Device Component 949 1680
Unintended System Motion 755 756
Appropriate Term/Code Not Available 684 684
Failure to Cut 523 523
Intermittent Loss of Power 502 502
Overheating of Device 472 658
Device-Device Incompatibility 404 404
Fluid/Blood Leak 302 847
Device Remains Activated 230 827
Unexpected Shutdown 175 175
Vibration 162 162
Material Fragmentation 157 242
Material Disintegration 156 401
Material Twisted/Bent 156 156
Naturally Worn 153 153
Leak/Splash 148 148
Intermittent Energy Output 133 133
Device Slipped 130 130
Premature Separation 110 110
Mechanical Problem 109 111
Entrapment of Device 104 104
Fail-Safe Problem 103 242
Fail-Safe Did Not Operate 99 158
Flaked 95 946
Material Deformation 78 79
Crack 69 69
Adverse Event Without Identified Device or Use Problem 68 68
Corroded 67 67
Defective Device 62 62
Difficult to Open or Close 58 251
Material Separation 56 56
Unintended Movement 43 43
Energy Output Problem 42 42
Unintended Power Up 40 48
Material Integrity Problem 40 40
Dull, Blunt 38 38
Compatibility Problem 31 31
Electrical /Electronic Property Problem 30 30
Smoking 29 29
Material Split, Cut or Torn 25 25
Environmental Particulates 24 24
Contamination /Decontamination Problem 23 23
Difficult or Delayed Separation 22 22
Component Missing 20 20
Device Emits Odor 20 20
Difficult to Remove 19 19
Use of Device Problem 18 18
Device Reprocessing Problem 18 18
Connection Problem 17 17
Separation Problem 16 16
Device Markings/Labelling Problem 14 14
No Apparent Adverse Event 14 14
Circuit Failure 14 14
Degraded 14 14
Positioning Failure 13 13
Fitting Problem 13 13
Improper or Incorrect Procedure or Method 12 12
Device Damaged by Another Device 12 12
Fire 12 12
Loose or Intermittent Connection 11 11
Defective Component 11 11
Insufficient Information 11 11
Power Problem 11 11
Protective Measures Problem 10 10
Key or Button Unresponsive/not Working 10 10
Packaging Problem 9 9
Unintended Ejection 9 10
Failure to Cycle 8 8
Difficult to Insert 8 8
Scratched Material 8 8
Output Problem 8 8
Manufacturing, Packaging or Shipping Problem 7 7
Positioning Problem 7 7
Tear, Rip or Hole in Device Packaging 7 7
Delivered as Unsterile Product 7 50
Display or Visual Feedback Problem 7 7
Separation Failure 6 6
Temperature Problem 6 6
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Communication or Transmission Problem 5 5
Failure to Auto Stop 5 5
Contamination 5 5
Moisture Damage 5 5
Material Rupture 5 5
Failure to Power Up 5 5
Device Alarm System 4 4
Activation, Positioning or Separation Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Mechanics Altered 3 3
Explosion 3 3
Device Handling Problem 3 3
Failure to Shut Off 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11384 14696
No Consequences Or Impact To Patient 4562 5319
No Known Impact Or Consequence To Patient 905 1301
No Patient Involvement 511 1561
Insufficient Information 366 475
Foreign Body In Patient 359 359
Device Embedded In Tissue or Plaque 112 112
Not Applicable 99 99
No Code Available 91 91
Burn(s) 48 48
No Information 42 106
Injury 31 31
Skin Tears 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Unspecified Tissue Injury 16 16
Bone Fracture(s) 15 15
Superficial (First Degree) Burn 9 9
Unspecified Infection 8 8
Pain 8 8
Failure of Implant 7 7
Laceration(s) 6 6
Tissue Damage 6 6
Burn, Thermal 4 4
Cardiac Perforation 4 4
Abrasion 4 4
Infiltration into Tissue 3 3
Patient Problem/Medical Problem 3 3
Brain Injury 3 3
Full thickness (Third Degree) Burn 2 2
Hemorrhage/Bleeding 2 2
Skin Irritation 2 2
Perforation 2 2
Shock 1 1
Skin Discoloration 1 2
Sprain 1 1
Tinnitus 1 1
Damage to Ligament(s) 1 1
Nerve Damage 1 1
Arrhythmia 1 1
Hearing Impairment 1 1
Alteration In Body Temperature 1 1
Rupture 1 1
Non-union Bone Fracture 1 1
Swelling/ Edema 1 1
Limb Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Encore Medical, Lp II Jul-27-2019
-
-