• 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 dermatome
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGFD
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2020 433 433
2021 614 614
2022 545 545
2023 810 810
2024 797 797
2025 375 375

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1219 1219
Unstable 434 434
Patient Device Interaction Problem 377 377
Power Problem 369 369
Appropriate Term/Code Not Available 298 298
Intermittent Loss of Power 242 242
Gas/Air Leak 230 230
Calibration Problem 160 160
Material Frayed 143 143
Noise, Audible 131 131
Material Deformation 113 113
Mechanical Problem 113 113
Failure to Power Up 111 111
Naturally Worn 102 102
Component Missing 101 101
Corroded 79 79
Incorrect, Inadequate or Imprecise Result or Readings 78 78
Loose or Intermittent Connection 73 73
Physical Resistance/Sticking 71 71
Insufficient Information 68 68
Break 65 65
Output below Specifications 60 60
Fitting Problem 60 60
Output Problem 52 52
Electrical /Electronic Property Problem 42 42
Material Integrity Problem 33 33
Incorrect Measurement 30 30
Adverse Event Without Identified Device or Use Problem 30 30
Positioning Problem 25 25
Detachment of Device or Device Component 24 24
Material Twisted/Bent 24 24
Activation Problem 22 22
Structural Problem 22 22
Unexpected Shutdown 20 20
Vibration 19 19
Loss of Power 19 19
Pressure Problem 18 18
Material Split, Cut or Torn 15 15
Dull, Blunt 15 15
Overheating of Device 15 15
Failure to Disconnect 14 14
Connection Problem 12 12
Key or Button Unresponsive/not Working 10 10
Complete Loss of Power 10 10
Electrical Power Problem 9 9
Mechanical Jam 7 7
Degraded 7 7
Use of Device Problem 7 7
Fluid/Blood Leak 7 7
Misassembled 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2597 2597
Laceration(s) 314 314
Insufficient Information 191 191
No Consequences Or Impact To Patient 174 174
No Patient Involvement 170 170
Abrasion 131 131
No Known Impact Or Consequence To Patient 90 90
Unspecified Tissue Injury 63 63
Skin Tears 54 54
Scar Tissue 15 15
Injury 10 10
Impaired Healing 9 9
Localized Skin Lesion 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
No Code Available 6 6
Physical Asymmetry 6 6
Muscle/Tendon Damage 4 4
Patient Problem/Medical Problem 2 2
Failure of Implant 2 2
No Information 2 2
Burn(s) 2 2
Superficial (First Degree) Burn 1 1
Adhesion(s) 1 1
Scarring 1 1
Suture Abrasion 1 1
Crushing Injury 1 1
Hair Loss 1 1
Partial Hearing Loss 1 1
Wrinkling 1 1
Tissue Damage 1 1
Partial thickness (Second Degree) Burn 1 1
Headache 1 1
Full thickness (Third Degree) Burn 1 1
Tissue Breakdown 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Sep-12-2020
2 Zimmer Surgical Inc II Oct-06-2023
-
-