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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
Regulation Description Manual operating table and accessories and manual operating chair and accessories.
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
2020 464 464
2021 337 337
2022 56 56
2023 28 28
2024 68 68
2025 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 302 302
Unintended Movement 95 95
Unstable 94 94
Device Slipped 90 90
Loose or Intermittent Connection 53 53
Positioning Problem 42 42
Deformation Due to Compressive Stress 39 39
Physical Resistance/Sticking 37 37
Mechanics Altered 32 32
Break 32 32
Device Handling Problem 29 29
Positioning Failure 19 19
Fitting Problem 17 17
Adverse Event Without Identified Device or Use Problem 17 17
Leak/Splash 16 16
Mechanical Jam 14 14
Decrease in Pressure 13 13
Material Integrity Problem 12 12
Naturally Worn 12 12
Connection Problem 9 9
Fluid/Blood Leak 8 8
Detachment of Device or Device Component 7 7
Difficult to Open or Close 6 6
Defective Device 6 6
Material Twisted/Bent 6 6
Component Missing 6 6
Material Deformation 5 5
Insufficient Information 5 5
Device Dislodged or Dislocated 4 4
Delivered as Unsterile Product 3 3
Failure to Cut 3 3
Low Readings 3 3
Use of Device Problem 3 3
Noise, Audible 3 3
Contamination /Decontamination Problem 2 2
Device-Device Incompatibility 2 2
Degraded 2 2
Problem with Removal of Enzymatic Cleaner 2 2
Fracture 2 2
Material Fragmentation 2 2
Failure to Clean Adequately 2 2
Packaging Problem 2 2
Material Separation 2 2
Failure to Eject 2 2
Material Split, Cut or Torn 2 2
Overheating of Device 1 1
Nonstandard Device 1 1
Device Fell 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 435 435
No Known Impact Or Consequence To Patient 256 256
No Patient Involvement 106 106
No Consequences Or Impact To Patient 88 88
Laceration(s) 28 28
Insufficient Information 22 22
No Information 13 13
Injury 7 7
Abrasion 5 5
Fall 4 4
Bruise/Contusion 3 3
Pain 3 3
Bacterial Infection 2 2
Bone Fracture(s) 2 2
Head Injury 2 2
Hemorrhage/Bleeding 2 2
Neck Pain 2 2
Neck Stiffness 2 2
Needle Stick/Puncture 2 2
Multiple Fractures 2 2
Blister 2 2
Concussion 2 2
Airway Obstruction 1 1
Cellulitis 1 1
Erythema 1 1
Fasciitis 1 1
Skin Tears 1 1
Ambulation Difficulties 1 1
Limb Fracture 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1
Necrosis 1 1
Nerve Damage 1 1
Paresis 1 1
Septic Shock 1 1
Swelling 1 1
Convulsion/Seizure 1 1
Unspecified Respiratory Problem 1 1

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