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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 223 223

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 875 875
Fluid Leak 248 248
Failure to Cut 245 245
Break 177 177
Adverse Event Without Identified Device or Use Problem 132 132
Device Contamination with Chemical or Other Material 121 121
Contamination /Decontamination Problem 118 118
Dull, Blunt 77 77
Material Fragmentation 69 69
Device Operates Differently Than Expected 61 61
Insufficient Information 58 58
Detachment of Device or Device Component 51 51
Material Integrity Problem 49 49
Detachment Of Device Component 44 44
Therapeutic or Diagnostic Output Failure 39 39
Suction Problem 35 35
Component Missing 29 29
Contamination 29 29
Suction Failure 27 27
Difficult to Insert 26 26
Physical Resistance/Sticking 25 25
Material Puncture/Hole 24 24
Output Problem 24 24
Loose or Intermittent Connection 23 23
Manufacturing, Packaging or Shipping Problem 23 23
Noise, Audible 21 21
Material Separation 20 20
Difficult to Remove 18 18
Patient-Device Incompatibility 18 18
Contamination of Device Ingredient or Reagent 18 18
Pressure Problem 17 17
Activation, Positioning or SeparationProblem 15 15
Defective Device 15 15
Obstruction of Flow 15 15
Mechanical Problem 14 14
Gas Leak 14 14
Mechanics Altered 14 14
Fitting Problem 14 14
Material Frayed 14 14
Material Discolored 14 14
Delivered as Unsterile Product 13 13
Material Deformation 13 13
Appropriate Term/Code Not Available 13 13
Material Split, Cut or Torn 13 13
Hole In Material 13 13
Device Dislodged or Dislocated 12 12
Decrease in Suction 12 12
Sticking 12 12
Inability to Irrigate 11 11
Device Contaminated During Manufacture or Shipping 11 11
Entrapment of Device 10 10
Component Falling 10 10
Material Twisted/Bent 10 10
Packaging Problem 10 10
Difficult to Open or Close 10 10
Material Disintegration 10 10
Air Leak 9 9
Nonstandard Device 9 9
Device Slipped 9 9
Mechanical Jam 9 9
Infusion or Flow Problem 9 9
Aspiration Issue 9 9
Tear, Rip or Hole in Device Packaging 9 9
Product Quality Problem 8 8
Device Fell 8 8
Air/Gas in Device 8 8
No Flow 8 8
Activation Problem 7 7
Fire 7 7
Device Packaging Compromised 7 7
Material Too Rigid or Stiff 7 7
Crack 7 7
Disconnection 7 7
Kinked 7 7
Device Displays Incorrect Message 7 7
Device Damaged Prior to Use 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Defective Component 6 6
Improper or Incorrect Procedure or Method 6 6
Partial Blockage 6 6
Positioning Problem 6 6
Complete Blockage 6 6
Use of Device Problem 6 6
Physical Property Issue 6 6
Material Too Soft/Flexible 5 5
Degraded 5 5
Scratched Material 5 5
Electrical /Electronic Property Problem 5 5
Inadequacy of Device Shape and/or Size 5 5
Failure to Advance 5 5
Device Contamination With Biological Material 5 5
Device Inoperable 4 4
Unintended Movement 4 4
Collapse 4 4
Unintended Ejection 4 4
No Device Output 4 4
Difficult To Position 4 4
Structural Problem 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 385 385
No Patient Involvement 75 75
Foreign Body In Patient 66 66
Insufficient Information 60 60
No Information 54 54
No Code Available 51 51
Unspecified Infection 33 33
Device Embedded In Tissue or Plaque 30 30
Endophthalmitis 26 26
Inflammation 25 25
Toxicity 11 11
Rash 11 11
Hemorrhage/Bleeding 9 9
Itching Sensation 8 8
Burn(s) 8 8
Injury 8 8
Retinal Tear 7 7
Eye Injury 7 7
Toxic Anterior Segment Syndrome (TASS) 7 7
Tissue Damage 6 6
Retinal Detachment 5 5
Reaction 5 5
Erythema 5 5
Corneal Edema 5 5
Exposure to Body Fluids 5 5
Abrasion 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Complaint, Ill-Defined 5 5
Fluid Discharge 4 4
Capsular Bag Tear 4 4
Intraocular Pressure, Delayed, Uncontrolled 4 4
Skin Tears 4 4
Laceration(s) 4 4
Pain 4 4
Local Reaction 3 3
Eye Burn 3 3
Burn, Thermal 3 3
Visual Impairment 3 3
Intraocular Pressure Increased 3 3
Corneal Clouding/Hazing 3 3
Hyphema 2 2
Hypersensitivity/Allergic reaction 2 2
Abscess 2 2
Bacterial Infection 2 2
Death 2 2
Corneal Abrasion 2 2
Edema 2 2
Bone Fracture(s) 2 2
Loss of Vision 2 2
Skin Irritation 2 2
Swelling 2 2
Thrombus 2 2
Rupture 2 2
Sepsis 2 2
Needle Stick/Puncture 2 2
Superficial (First Degree) Burn 2 2
Missing Value Reason 2 2
Multiple Organ Failure 1 1
Eye Pain 1 1
Patient Problem/Medical Problem 1 1
Zonular Dehiscence 1 1
Prolapse 1 1
Vitrectomy 1 1
Muscle Hypotonia 1 1
Drug Resistant Bacterial Infection 1 1
Shock 1 1
Staphylococcus Aureus 1 1
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 1 1
Ulceration 1 1
Uveitis 1 1
Perforation of Vessels 1 1
Retinal Injury 1 1
Perforation 1 1
Pneumothorax 1 1
Discharge 1 1
Cardiac Tamponade 1 1
Distress 1 1
Discomfort 1 1
Vitreous Loss 1 1
Caustic/Chemical Burns 1 1
Blood Loss 1 1
Collapse 1 1
Loss of consciousness 1 1
Vitreous Detachment 1 1
Post Operative Wound Infection 1 1
Purulent Discharge 1 1
Failure to Anastomose 1 1
Abdominal Pain 1 1
Bruise/Contusion 1 1
Bowel Burn 1 1
Stroke/CVA 1 1
Chemosis 1 1
High Blood Pressure/ Hypertension 1 1
Keratitis 1 1
Hypopyon 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Failure of Implant 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. II Mar-19-2020
6 Avid Medical, Inc. II Feb-28-2018
7 Avid Medical, Inc. II Feb-09-2018
8 Avid Medical, Inc. II Aug-18-2016
9 Cardinal Health 200, LLC II Feb-04-2020
10 Cardinal Health 200, LLC II Feb-03-2020
11 Cardinal Health 200, LLC II Aug-14-2017
12 Cardinal Health Inc. II Jan-09-2019
13 Centurion Medical Products Corporation II Feb-05-2020
14 Centurion Medical Products Corporation II Nov-06-2019
15 Centurion Medical Products Corporation II Oct-31-2019
16 Covidien LLC II Nov-08-2016
17 Custom Assemblies Inc II Aug-22-2017
18 Custom Healthcare Systems, Inc. II Jan-24-2020
19 Custom Healthcare Systems, Inc. II Oct-25-2018
20 Customed, Inc II Apr-14-2016
21 DeRoyal Industries Inc II Feb-19-2021
22 DeRoyal Industries Inc II Jul-16-2019
23 DeRoyal Industries Inc II Feb-16-2018
24 DeRoyal Industries Inc II Jan-12-2018
25 DeRoyal Industries Inc II Dec-06-2017
26 DeRoyal Industries Inc III Feb-23-2017
27 DeRoyal Industries Inc II Aug-26-2016
28 Deroyal Industries, Inc. Lafollette II Feb-19-2020
29 Encore Medical, Lp II Aug-02-2018
30 Gi Supply II Mar-04-2016
31 Medline Industries Inc II Jan-07-2021
32 Medline Industries Inc II May-15-2020
33 Medline Industries Inc II Mar-20-2020
34 ROi CPS LLC II Jan-30-2020
35 Resource Optimization & Innovation Llc II Nov-21-2017
36 Resource Optimization & Innovation Llc II Mar-24-2017
37 Stryker GmbH II Mar-06-2019
38 Windstone Medical Packaging, Inc. II Nov-07-2017
39 Wright Medical Technology, Inc. II Aug-13-2020
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