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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device expander, surgical, skin graft
Regulation Description Manual surgical instrument for general use.
Product CodeFZW
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2016 19 19
2017 446 446
2018 480 480
2019 468 468
2020 486 486
2021 228 228

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 1181 1181
Material Twisted/Bent 441 441
Bent 156 156
Device Operates Differently Than Expected 121 121
Mechanical Jam 99 99
Physical Resistance/Sticking 89 89
Difficult to Remove 48 48
Mechanical Problem 37 37
Break 31 31
Appropriate Term/Code Not Available 20 20
Material Deformation 19 19
Component Missing 18 18
Difficult to Advance 16 16
Dull, Blunt 14 14
Sticking 11 11
Device Damaged Prior to Use 11 11
Device Contaminated During Manufacture or Shipping 11 11
Output Problem 11 11
Naturally Worn 9 9
Material Too Rigid or Stiff 8 8
Difficult to Open or Close 7 7
Material Split, Cut or Torn 7 7
Fitting Problem 6 6
Defective Component 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Expiration Date Error 5 5
Fracture 5 5
Difficult To Position 4 4
Calibration Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Corroded 4 4
Mechanics Altered 4 4
Defective Device 3 3
Metal Shedding Debris 3 3
Failure to Align 3 3
Device Slipped 3 3
Incorrect Measurement 3 3
Disassembly 3 3
Insufficient Information 3 3
Patient Device Interaction Problem 3 3
Crack 2 2
Positioning Failure 2 2
Loss of Power 2 2
Incorrect, Inadequate or Imprecise Resultor Readings 2 2
Separation Failure 2 2
Delivered as Unsterile Product 2 2
Failure to Advance 2 2
Dent in Material 2 2
Contamination /Decontamination Problem 2 2
Connection Problem 2 2
Material Integrity Problem 2 2
Failure to Clean Adequately 1 1
Positioning Problem 1 1
Power Problem 1 1
Device Difficult to Maintain 1 1
Activation Failure 1 1
Free or Unrestricted Flow 1 1
Improper Device Output 1 1
Compatibility Problem 1 1
Failure to Disconnect 1 1
Improper or Incorrect Procedure or Method 1 1
Product Quality Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Partial Blockage 1 1
Detachment Of Device Component 1 1
Material Discolored 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Misassembled 1 1
Use of Device Problem 1 1
Cut In Material 1 1
Wrinkled 1 1
Detachment of Device or Device Component 1 1
Gas Leak 1 1
Device Operational Issue 1 1
Device Damaged by Another Device 1 1
No Device Output 1 1
Degraded 1 1
Material Disintegration 1 1
Material Fragmentation 1 1
Device Handling Problem 1 1
Activation Problem 1 1
Operating System Becomes Nonfunctional 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 779 779
No Patient Involvement 604 604
No Known Impact Or Consequence To Patient 507 507
No Clinical Signs, Symptoms or Conditions 186 186
Abrasion 78 78
No Information 45 45
No Code Available 41 41
Laceration(s) 13 13
Injury 8 8
Tissue Damage 7 7
Insufficient Information 3 3
Skin Tears 2 2
Oversedation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Molnlycke Health Care, Inc II May-03-2017
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