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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device operating room accessories table tray
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeFWZ
Regulation Number 878.4950
Device Class 1

MDR Year MDR Reports MDR Events
2018 120 120
2019 99 99
2020 464 464
2021 337 337
2022 56 56
2023 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 330 330
Unintended Movement 114 114
Device Slipped 79 79
Unstable 79 79
Loose or Intermittent Connection 78 78
Break 73 73
Positioning Problem 46 46
Deformation Due to Compressive Stress 39 39
Physical Resistance/Sticking 31 31
Mechanics Altered 30 30
Positioning Failure 29 29
Device Handling Problem 28 28
Leak/Splash 21 21
Fitting Problem 18 18
Naturally Worn 16 16
Adverse Event Without Identified Device or Use Problem 15 15
Mechanical Jam 15 15
Decrease in Pressure 13 13
Material Integrity Problem 12 12
Insufficient Information 10 10
Connection Problem 10 10
Detachment of Device or Device Component 9 9
Component Missing 9 9
Fluid/Blood Leak 9 9
Device Dislodged or Dislocated 7 7
Material Deformation 6 6
Material Twisted/Bent 5 5
Noise, Audible 5 5
Difficult to Open or Close 5 5
Failure to Cut 4 4
Defective Device 4 4
Material Split, Cut or Torn 4 4
Appropriate Term/Code Not Available 3 3
Device Operates Differently Than Expected 3 3
Fracture 3 3
Low Readings 3 3
Use of Device Problem 3 3
Off-Label Use 3 3
Device Inoperable 3 3
Failure to Clean Adequately 3 3
Device Fell 2 2
Material Too Rigid or Stiff 2 2
Product Quality Problem 2 2
Material Fragmentation 2 2
Collapse 2 2
Detachment Of Device Component 2 2
Problem with Removal of Enzymatic Cleaner 2 2
Unintended System Motion 2 2
Material Separation 2 2
Contamination /Decontamination Problem 2 2
Pressure Problem 2 2
Failure to Eject 2 2
Packaging Problem 1 1
Device Markings/Labelling Problem 1 1
Device Tipped Over 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Device-Device Incompatibility 1 1
Device Contamination with Chemical or Other Material 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Migration or Expulsion of Device 1 1
Bent 1 1
Crack 1 1
Material Frayed 1 1
Inflation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Puncture/Hole 1 1
Material Rupture 1 1
Vibration 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Split 1 1
Incomplete or Missing Packaging 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 366 366
No Known Impact Or Consequence To Patient 335 335
No Consequences Or Impact To Patient 197 197
No Patient Involvement 118 118
Laceration(s) 18 18
No Information 14 14
Injury 10 10
Insufficient Information 8 8
Fall 5 5
Bone Fracture(s) 4 4
Pain 3 3
No Code Available 3 3
Needle Stick/Puncture 2 2
Bruise/Contusion 2 2
Cellulitis 1 1
Erythema 1 1
Abrasion 1 1
Airway Obstruction 1 1
Bacterial Infection 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
High Blood Pressure/ Hypertension 1 1
Unspecified Infection 1 1
Inflammation 1 1
Paresis 1 1
Swelling 1 1
Tissue Damage 1 1
Necrosis 1 1
Hernia 1 1
Skin Tears 1 1
Ambulation Difficulties 1 1
Blood Loss 1 1
Limb Fracture 1 1
Blister 1 1
Swelling/ Edema 1 1
Fasciitis 1 1

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