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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device general surgery tray
Regulation Description Surgical drape and drape 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 CodeLRO
Regulation Number 878.4370
Device Class 2

MDR Year MDR Reports MDR Events
2016 804 804
2017 523 523
2018 384 384
2019 406 406
2020 767 767
2021 647 647

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 875 875
Failure to Cut 327 327
Fluid Leak 309 309
Break 210 210
Adverse Event Without Identified Device or Use Problem 177 177
Contamination /Decontamination Problem 136 136
Device Contamination with Chemical or Other Material 133 133
Dull, Blunt 84 84
Material Fragmentation 75 75
Detachment of Device or Device Component 67 67
Device Operates Differently Than Expected 61 61
Insufficient Information 58 58
Suction Failure 58 58
Material Integrity Problem 50 50
Suction Problem 49 49
Contamination 45 45
Detachment Of Device Component 44 44
Therapeutic or Diagnostic Output Failure 39 39
Component Missing 32 32
Difficult to Insert 30 30
Material Puncture/Hole 29 29
Noise, Audible 26 26
Physical Resistance/Sticking 26 26
Manufacturing, Packaging or Shipping Problem 25 25
Loose or Intermittent Connection 25 25
Material Separation 25 25
Output Problem 24 24
Air/Gas in Device 23 23
Obstruction of Flow 23 23
Inability to Irrigate 19 19
Difficult to Remove 18 18
Contamination of Device Ingredient or Reagent 18 18
Patient-Device Incompatibility 18 18
Defective Device 17 17
Fitting Problem 17 17
Decrease in Suction 17 17
Pressure Problem 17 17
Appropriate Term/Code Not Available 16 16
Gas Leak 16 16
Activation, Positioning or SeparationProblem 15 15
Material Discolored 15 15
Delivered as Unsterile Product 15 15
Mechanical Problem 14 14
Material Frayed 14 14
Device Dislodged or Dislocated 14 14
Mechanics Altered 14 14
Device Contaminated During Manufacture or Shipping 14 14
Material Deformation 13 13
Material Twisted/Bent 13 13
Material Split, Cut or Torn 13 13
Tear, Rip or Hole in Device Packaging 13 13
Hole In Material 13 13
Product Quality Problem 12 12
Sticking 12 12
Infusion or Flow Problem 12 12
Device Slipped 11 11
Difficult to Open or Close 10 10
Material Disintegration 10 10
Entrapment of Device 10 10
Component Falling 10 10
Complete Blockage 10 10
Packaging Problem 10 10
Mechanical Jam 9 9
Material Too Soft/Flexible 9 9
No Flow 9 9
Air Leak 9 9
Particulates 9 9
Aspiration Issue 9 9
Nonstandard Device 9 9
Use of Device Problem 8 8
Device Displays Incorrect Message 8 8
Device Fell 8 8
Activation Problem 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Device Packaging Compromised 7 7
Material Too Rigid or Stiff 7 7
Device Damaged Prior to Use 7 7
Fire 7 7
Kinked 7 7
Crack 7 7
Disconnection 7 7
Partial Blockage 6 6
Defective Component 6 6
Improper or Incorrect Procedure or Method 6 6
Inadequacy of Device Shape and/or Size 6 6
Failure to Advance 6 6
Physical Property Issue 6 6
Positioning Problem 6 6
Scratched Material 5 5
Unintended Movement 5 5
Device Contamination With Biological Material 5 5
Degraded 5 5
Electrical /Electronic Property Problem 5 5
Unintended Ejection 4 4
Loss of or Failure to Bond 4 4
Collapse 4 4
No Device Output 4 4
Difficult To Position 4 4
Device Or Device Fragments Location Unknown 4 4
Sparking 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1153 1153
No Consequences Or Impact To Patient 984 984
No Clinical Signs, Symptoms or Conditions 696 696
Insufficient Information 102 102
Foreign Body In Patient 77 77
No Patient Involvement 75 75
No Information 54 54
No Code Available 51 51
Inflammation 44 44
Endophthalmitis 38 38
Unspecified Infection 35 35
Device Embedded In Tissue or Plaque 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 26 26
Toxic Anterior Segment Syndrome (TASS) 20 20
Uveitis 15 15
Hemorrhage/Bleeding 14 14
Corneal Edema 12 12
Toxicity 11 11
Rash 11 11
Retinal Tear 10 10
Burn(s) 10 10
Vitritis 9 9
Itching Sensation 9 9
Eye Injury 8 8
Capsular Bag Tear 8 8
Injury 8 8
Eye Burn 7 7
Hypopyon 7 7
Retinal Detachment 7 7
Tissue Damage 6 6
Complaint, Ill-Defined 5 5
Loss of Vision 5 5
Reaction 5 5
Blurred Vision 5 5
Exposure to Body Fluids 5 5
Abrasion 5 5
Erythema 5 5
Conjunctivitis 4 4
Skin Tears 4 4
Fluid Discharge 4 4
Visual Impairment 4 4
Pain 4 4
Intraocular Pressure, Delayed, Uncontrolled 4 4
Laceration(s) 4 4
Eye Pain 4 4
Intraocular Pressure Decreased 3 3
Burn, Thermal 3 3
Fibrosis 3 3
Intraocular Pressure Increased 3 3
Local Reaction 3 3
Bacterial Infection 3 3
Corneal Clouding/Hazing 3 3
Superficial (First Degree) Burn 3 3
Prolapse 2 2
Corneal Abrasion 2 2
Hypersensitivity/Allergic reaction 2 2
Abscess 2 2
Sepsis 2 2
Skin Irritation 2 2
Swelling 2 2
Thrombus 2 2
Vitreous Loss 2 2
Rupture 2 2
Edema 2 2
Bone Fracture(s) 2 2
Death 2 2
Hyphema 2 2
Optical Nerve Damage 2 2
Needle Stick/Puncture 2 2
Missing Value Reason 2 2
Drug Resistant Bacterial Infection 1 1
Blood Loss 1 1
Patient Problem/Medical Problem 1 1
Zonular Dehiscence 1 1
Vitreous Detachment 1 1
Post Operative Wound Infection 1 1
Distress 1 1
Discomfort 1 1
Keratitis 1 1
Hypoxia 1 1
Pneumothorax 1 1
Shock 1 1
Purulent Discharge 1 1
Abdominal Pain 1 1
Bruise/Contusion 1 1
Stroke/CVA 1 1
Corneal Ulcer 1 1
Foreign Body Sensation in Eye 1 1
Hemolysis 1 1
Hyperemia 1 1
Discharge 1 1
Cardiac Tamponade 1 1
Failure to Anastomose 1 1
Collapse 1 1
Loss of consciousness 1 1
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 1 1
Ulceration 1 1
Perforation of Vessels 1 1
Staphylococcus Aureus 1 1
Retinal Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, LLC II Apr-01-2021
2 Alcon Research, LLC II Oct-09-2020
3 Alcon Research, LTD. II Aug-25-2017
4 American Contract Systems II May-29-2020
5 Avid Medical, Inc. I Jun-04-2021
6 Avid Medical, Inc. II Mar-19-2020
7 Avid Medical, Inc. II Feb-28-2018
8 Avid Medical, Inc. II Feb-09-2018
9 Avid Medical, Inc. II Aug-18-2016
10 Cardinal Health 200, LLC II Feb-04-2020
11 Cardinal Health 200, LLC II Feb-03-2020
12 Cardinal Health 200, LLC II Aug-14-2017
13 Cardinal Health Inc. II Jan-09-2019
14 Centurion Medical Products Corporation II Feb-05-2020
15 Centurion Medical Products Corporation II Nov-06-2019
16 Centurion Medical Products Corporation II Oct-31-2019
17 Covidien LLC II Nov-08-2016
18 Custom Assemblies Inc II Aug-22-2017
19 Custom Healthcare Systems, Inc. II Jan-24-2020
20 Custom Healthcare Systems, Inc. II Oct-25-2018
21 Customed, Inc II Apr-14-2016
22 DeRoyal Industries Inc I Jun-10-2021
23 DeRoyal Industries Inc II Feb-19-2021
24 DeRoyal Industries Inc II Jul-16-2019
25 DeRoyal Industries Inc II Feb-16-2018
26 DeRoyal Industries Inc II Jan-12-2018
27 DeRoyal Industries Inc II Dec-06-2017
28 DeRoyal Industries Inc III Feb-23-2017
29 DeRoyal Industries Inc II Aug-26-2016
30 Deroyal Industries, Inc. Lafollette I Sep-29-2021
31 Deroyal Industries, Inc. Lafollette II Feb-19-2020
32 Encore Medical, Lp II Aug-02-2018
33 Gi Supply II Mar-04-2016
34 Medical Action Industries, Inc. 306 II Jun-24-2021
35 Medline Industries Inc II Jun-09-2021
36 Medline Industries Inc II Jan-07-2021
37 Medline Industries Inc II May-15-2020
38 Medline Industries Inc II Mar-20-2020
39 ROi CPS LLC II Jan-30-2020
40 Resource Optimization & Innovation Llc II Nov-21-2017
41 Resource Optimization & Innovation Llc II Mar-24-2017
42 Stryker GmbH II Mar-06-2019
43 Windstone Medical Packaging, Inc. II Nov-07-2017
44 Wright Medical Technology, Inc. II Aug-13-2020
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