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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 480 480

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 875 875
Failure to Cut 298 298
Fluid Leak 278 278
Break 190 190
Adverse Event Without Identified Device or Use Problem 169 169
Device Contamination with Chemical or Other Material 130 130
Contamination /Decontamination Problem 124 124
Dull, Blunt 78 78
Material Fragmentation 71 71
Device Operates Differently Than Expected 61 61
Insufficient Information 58 58
Detachment of Device or Device Component 53 53
Material Integrity Problem 50 50
Suction Failure 47 47
Detachment Of Device Component 44 44
Suction Problem 44 44
Contamination 43 43
Therapeutic or Diagnostic Output Failure 39 39
Component Missing 30 30
Difficult to Insert 28 28
Material Puncture/Hole 27 27
Physical Resistance/Sticking 26 26
Loose or Intermittent Connection 25 25
Manufacturing, Packaging or Shipping Problem 24 24
Output Problem 24 24
Noise, Audible 23 23
Material Separation 23 23
Obstruction of Flow 22 22
Difficult to Remove 18 18
Patient-Device Incompatibility 18 18
Contamination of Device Ingredient or Reagent 18 18
Inability to Irrigate 18 18
Air/Gas in Device 18 18
Pressure Problem 17 17
Decrease in Suction 16 16
Fitting Problem 16 16
Defective Device 16 16
Gas Leak 16 16
Activation, Positioning or SeparationProblem 15 15
Material Discolored 15 15
Delivered as Unsterile Product 15 15
Material Frayed 14 14
Mechanics Altered 14 14
Device Dislodged or Dislocated 14 14
Mechanical Problem 14 14
Appropriate Term/Code Not Available 14 14
Material Split, Cut or Torn 13 13
Material Twisted/Bent 13 13
Hole In Material 13 13
Tear, Rip or Hole in Device Packaging 13 13
Material Deformation 13 13
Device Contaminated During Manufacture or Shipping 12 12
Sticking 12 12
Product Quality Problem 11 11
Device Slipped 11 11
Material Disintegration 10 10
Difficult to Open or Close 10 10
Packaging Problem 10 10
Entrapment of Device 10 10
Component Falling 10 10
Aspiration Issue 9 9
No Flow 9 9
Mechanical Jam 9 9
Infusion or Flow Problem 9 9
Material Too Soft/Flexible 9 9
Air Leak 9 9
Nonstandard Device 9 9
Complete Blockage 8 8
Use of Device Problem 8 8
Device Fell 8 8
Device Misassembled During Manufacturing /Shipping 7 7
Device Damaged Prior to Use 7 7
Device Displays Incorrect Message 7 7
Disconnection 7 7
Kinked 7 7
Device Packaging Compromised 7 7
Material Too Rigid or Stiff 7 7
Crack 7 7
Fire 7 7
Activation Problem 7 7
Physical Property Issue 6 6
Partial Blockage 6 6
Inadequacy of Device Shape and/or Size 6 6
Improper or Incorrect Procedure or Method 6 6
Defective Component 6 6
Positioning Problem 6 6
Scratched Material 5 5
Unintended Movement 5 5
Failure to Advance 5 5
Device Contamination With Biological Material 5 5
Electrical /Electronic Property Problem 5 5
Degraded 5 5
Collapse 4 4
Unintended Ejection 4 4
No Device Output 4 4
Particulates 4 4
Difficult To Position 4 4
Device Or Device Fragments Location Unknown 4 4
Sparking 4 4
Structural Problem 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 567 567
Insufficient Information 84 84
No Patient Involvement 75 75
Foreign Body In Patient 72 72
No Information 54 54
No Code Available 51 51
Inflammation 40 40
Endophthalmitis 35 35
Unspecified Infection 33 33
Device Embedded In Tissue or Plaque 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Toxic Anterior Segment Syndrome (TASS) 19 19
Uveitis 12 12
Toxicity 11 11
Rash 11 11
Burn(s) 10 10
Corneal Edema 10 10
Hemorrhage/Bleeding 10 10
Vitritis 9 9
Retinal Tear 8 8
Itching Sensation 8 8
Injury 8 8
Capsular Bag Tear 7 7
Eye Injury 7 7
Hypopyon 6 6
Tissue Damage 6 6
Eye Burn 6 6
Complaint, Ill-Defined 5 5
Loss of Vision 5 5
Reaction 5 5
Retinal Detachment 5 5
Exposure to Body Fluids 5 5
Erythema 5 5
Abrasion 5 5
Conjunctivitis 4 4
Skin Tears 4 4
Fluid Discharge 4 4
Pain 4 4
Intraocular Pressure, Delayed, Uncontrolled 4 4
Laceration(s) 4 4
Visual Impairment 4 4
Eye Pain 4 4
Fibrosis 3 3
Burn, Thermal 3 3
Intraocular Pressure Increased 3 3
Local Reaction 3 3
Bacterial Infection 3 3
Corneal Clouding/Hazing 3 3
Edema 2 2
Bone Fracture(s) 2 2
Death 2 2
Hyphema 2 2
Blurred Vision 2 2
Optical Nerve Damage 2 2
Needle Stick/Puncture 2 2
Missing Value Reason 2 2
Intraocular Pressure Decreased 2 2
Superficial (First Degree) Burn 2 2
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
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
Bowel Burn 1 1
Chemosis 1 1
Hematoma 1 1
Hemorrhage, Cerebral 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Perforation 1 1
Caustic/Chemical Burns 1 1
Vitrectomy 1 1
Multiple Organ Failure 1 1
Muscle Hypotonia 1 1
Drug Resistant Bacterial Infection 1 1
Blood Loss 1 1
Patient Problem/Medical Problem 1 1
Zonular Dehiscence 1 1
Distress 1 1
Discomfort 1 1
Vitreous Detachment 1 1
Post Operative Wound Infection 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 II Feb-19-2020
31 Encore Medical, Lp II Aug-02-2018
32 Gi Supply II Mar-04-2016
33 Medical Action Industries, Inc. 306 II Jun-24-2021
34 Medline Industries Inc II Jun-09-2021
35 Medline Industries Inc II Jan-07-2021
36 Medline Industries Inc II May-15-2020
37 Medline Industries Inc II Mar-20-2020
38 ROi CPS LLC II Jan-30-2020
39 Resource Optimization & Innovation Llc II Nov-21-2017
40 Resource Optimization & Innovation Llc II Mar-24-2017
41 Stryker GmbH II Mar-06-2019
42 Windstone Medical Packaging, Inc. II Nov-07-2017
43 Wright Medical Technology, Inc. II Aug-13-2020
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