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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
2019 99 99
2020 464 464
2021 337 337
2022 56 56
2023 28 28
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 329 329
Unintended Movement 111 111
Unstable 83 83
Device Slipped 80 80
Loose or Intermittent Connection 58 58
Positioning Problem 43 43
Deformation Due to Compressive Stress 39 39
Break 38 38
Physical Resistance/Sticking 37 37
Mechanics Altered 30 30
Positioning Failure 29 29
Device Handling Problem 28 28
Leak/Splash 18 18
Fitting Problem 18 18
Adverse Event Without Identified Device or Use Problem 17 17
Mechanical Jam 16 16
Naturally Worn 16 16
Decrease in Pressure 13 13
Material Integrity Problem 12 12
Fluid/Blood Leak 9 9
Connection Problem 9 9
Insufficient Information 9 9
Material Twisted/Bent 7 7
Component Missing 7 7
Difficult to Open or Close 6 6
Detachment of Device or Device Component 6 6
Defective Device 6 6
Material Deformation 5 5
Device Dislodged or Dislocated 4 4
Failure to Cut 4 4
Noise, Audible 3 3
Fracture 3 3
Low Readings 3 3
Use of Device Problem 3 3
Material Split, Cut or Torn 3 3
Material Fragmentation 2 2
Failure to Clean Adequately 2 2
Packaging Problem 2 2
Material Separation 2 2
Problem with Removal of Enzymatic Cleaner 2 2
Failure to Eject 2 2
Device-Device Incompatibility 2 2
Battery Problem 1 1
Contamination /Decontamination Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Too Rigid or Stiff 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Fell 1 1
Patient-Device Incompatibility 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 408 408
No Known Impact Or Consequence To Patient 275 275
No Consequences Or Impact To Patient 151 151
No Patient Involvement 114 114
Laceration(s) 23 23
Insufficient Information 18 18
No Information 13 13
Injury 10 10
Fall 4 4
Pain 3 3
Needle Stick/Puncture 2 2
Hemorrhage/Bleeding 2 2
Unspecified Infection 1 1
Necrosis 1 1
Bone Fracture(s) 1 1
Inflammation 1 1
Abrasion 1 1
Blister 1 1
Cellulitis 1 1
Erythema 1 1
Nerve Damage 1 1
Swelling 1 1
Paresis 1 1
Limb Fracture 1 1
Fasciitis 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Tissue Damage 1 1
Skin Tears 1 1
Bacterial Infection 1 1
Airway Obstruction 1 1
Bruise/Contusion 1 1
Ambulation Difficulties 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Mar-12-2024
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