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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
2016 59 59
2017 102 102
2018 119 119
2019 99 99
2020 464 464
2021 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 183 183
Break 109 109
Unintended Movement 89 89
Loose or Intermittent Connection 75 75
Device Slipped 68 68
Positioning Problem 53 53
Deformation Due to Compressive Stress 40 40
Unstable 39 39
Device Operates Differently Than Expected 39 39
Device Handling Problem 28 28
Positioning Failure 27 27
Physical Resistance/Sticking 21 21
Material Integrity Problem 19 19
Fitting Problem 17 17
Insufficient Information 16 16
Leak/Splash 14 14
Naturally Worn 12 12
Detachment Of Device Component 11 11
Connection Problem 10 10
Component Missing 9 9
Clamp 9 9
Fluid Leak 9 9
Detachment of Device or Device Component 8 8
Mechanical Jam 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Device Dislodged or Dislocated 7 7
Noise, Audible 7 7
Material Deformation 6 6
Screw 6 6
Difficult to Open or Close 5 5
Pressure Problem 5 5
Appropriate Term/Code Not Available 5 5
Device Subassembly 4 4
Device Packaging Compromised 4 4
Knob 4 4
Fracture 4 4
Crack 4 4
Defective Device 4 4
Product Quality Problem 4 4
Use of Device Problem 4 4
Device Inoperable 3 3
Decrease in Pressure 3 3
Off-Label Use 3 3
Material Separation 3 3
Low Readings 3 3
Bent 3 3
Material Fragmentation 3 3
Component Falling 3 3
Collapse 3 3
Material Twisted/Bent 3 3
Material Split, Cut or Torn 3 3
Weld 3 3
Failure to Clean Adequately 3 3
Device Fell 2 2
Failure to Eject 2 2
Handpiece 2 2
Mechanics Altered 2 2
Pin 2 2
Failure To Adhere Or Bond 2 2
Bolt 2 2
Device Maintenance Issue 2 2
Problem with Removal of Enzymatic Cleaner 2 2
Migration or Expulsion of Device 2 2
Unintended System Motion 2 2
Difficult To Position 2 2
Device Tipped Over 2 2
Patient-Device Incompatibility 2 2
Material Too Rigid or Stiff 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Vibration 1 1
Metal Shedding Debris 1 1
Material Rupture 1 1
Material Puncture/Hole 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Battery Problem 1 1
Device Markings/Labelling Problem 1 1
Contamination /Decontamination Problem 1 1
Failure to Advance 1 1
Split 1 1
Failure to Cut 1 1
Residue After Decontamination 1 1
Device Issue 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Power Up 1 1
Flaked 1 1
Material Frayed 1 1
Unintended Head Motion 1 1
Inflation Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Disassembly 1 1
Adapter (Adaptor) 1 1
Valve(s) 1 1
Lock 1 1
Cover 1 1
Unintended Arm Motion 1 1
Plate 1 1
Air Leak 1 1
Temperature Problem 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 410 410
No Consequences Or Impact To Patient 243 243
No Patient Involvement 134 134
No Clinical Signs, Symptoms or Conditions 50 50
No Information 23 23
Injury 17 17
Laceration(s) 13 13
Fall 10 10
No Code Available 6 6
Bone Fracture(s) 5 5
Bruise/Contusion 3 3
Pressure Sores 3 3
Erythema 2 2
Complaint, Ill-Defined 2 2
Head Injury 2 2
Hemorrhage/Bleeding 1 1
Unspecified Infection 1 1
Hair Loss 1 1
Pain 1 1
Paralysis 1 1
Skull Fracture 1 1
Tissue Damage 1 1
Discomfort 1 1
Blood Loss 1 1
Limb Fracture 1 1
Abrasion 1 1
Hernia 1 1
Hematoma 1 1
High Blood Pressure/ Hypertension 1 1
Inflammation 1 1
Loss of Range of Motion 1 1
Skin Irritation 1 1
Swelling 1 1
Numbness 1 1
Skin Tears 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mizuho OSI II Apr-19-2017
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