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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 318 318

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1201 1201
Unstable 434 434
Patient Device Interaction Problem 377 377
Power Problem 368 368
Appropriate Term/Code Not Available 292 292
Intermittent Loss of Power 242 242
Gas/Air Leak 227 227
Calibration Problem 157 157
Material Frayed 142 142
Noise, Audible 130 130
Material Deformation 112 112
Mechanical Problem 110 110
Failure to Power Up 109 109
Component Missing 100 100
Naturally Worn 99 99
Incorrect, Inadequate or Imprecise Result or Readings 78 78
Corroded 75 75
Loose or Intermittent Connection 73 73
Physical Resistance/Sticking 70 70
Insufficient Information 68 68
Break 64 64
Fitting Problem 58 58
Output Problem 52 52
Output below Specifications 52 52
Electrical /Electronic Property Problem 42 42
Material Integrity Problem 32 32
Adverse Event Without Identified Device or Use Problem 30 30
Incorrect Measurement 28 28
Positioning Problem 25 25
Detachment of Device or Device Component 24 24
Material Twisted/Bent 22 22
Structural Problem 22 22
Activation Problem 21 21
Loss of Power 19 19
Vibration 19 19
Pressure Problem 18 18
Unexpected Shutdown 18 18
Dull, Blunt 15 15
Material Split, Cut or Torn 15 15
Failure to Disconnect 14 14
Overheating of Device 13 13
Connection Problem 12 12
Key or Button Unresponsive/not Working 10 10
Complete Loss of Power 9 9
Electrical Power Problem 9 9
Fluid/Blood Leak 7 7
Mechanical Jam 7 7
Degraded 7 7
Use of Device Problem 7 7
Misassembled 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2558 2558
Laceration(s) 310 310
No Consequences Or Impact To Patient 174 174
No Patient Involvement 170 170
Insufficient Information 165 165
Abrasion 131 131
No Known Impact Or Consequence To Patient 90 90
Unspecified Tissue Injury 62 62
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
Crushing Injury 1 1
Scarring 1 1
Suture Abrasion 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
Tissue Breakdown 1 1
Full thickness (Third Degree) Burn 1 1

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