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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
2015 626 626
2016 804 804
2017 523 523
2018 384 384
2019 406 406
2020 548 548

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1211 1211
Trocar 828 828
Valve(s) 366 366
Fluid Leak 224 224
Cannula 178 178
Break 174 174
Failure to Cut 141 141
Device Contamination with Chemical or Other Material 133 133
Adverse Event Without Identified Device or Use Problem 122 122
Dull, Blunt 119 119
Device Operates Differently Than Expected 111 111
Contamination /Decontamination Problem 110 110
Knife 94 94
Tip 92 92
Insufficient Information 82 82
Material Fragmentation 71 71
Probe 70 70
Detachment Of Device Component 60 60
Material Integrity Problem 52 52
Detachment of Device or Device Component 49 49
Therapeutic or Diagnostic Output Failure 27 27
Component Missing 27 27
Suction Problem 25 25
Cassette 25 25
Difficult to Insert 25 25
Loose or Intermittent Connection 22 22
Tube 22 22
Material Puncture/Hole 22 22
Contamination 21 21
Manufacturing, Packaging or Shipping Problem 20 20
Hole In Material 19 19
Cutter/Blade 18 18
Patient-Device Incompatibility 18 18
Difficult to Remove 17 17
Pressure Problem 17 17
Contamination of Device Ingredient or Reagent 17 17
Sticking 17 17
Component Falling 16 16
Fiber 15 15
Activation, Positioning or SeparationProblem 15 15
Air Leak 15 15
Material Frayed 15 15
Material Discolored 15 15
Physical Resistance/Sticking 15 15
Material Separation 14 14
Mechanical Problem 13 13
Defective Device 13 13
Device Dislodged or Dislocated 13 13
Appropriate Term/Code Not Available 13 13
Mechanics Altered 13 13
Delivered as Unsterile Product 12 12
Material Split, Cut or Torn 12 12
Gas Leak 11 11
Device Slipped 11 11
Material Deformation 11 11
Device Contaminated During Manufacture or Shipping 11 11
Device Subassembly 10 10
Aspiration Issue 10 10
Kinked 10 10
Material Disintegration 10 10
Device Packaging Compromised 10 10
Output Problem 10 10
Packaging Problem 10 10
Material Twisted/Bent 10 10
Needle 9 9
Nonstandard Device 9 9
Device Inoperable 9 9
Suction Failure 9 9
Device Fell 8 8
Product Quality Problem 8 8
Fitting Problem 8 8
Entrapment of Device 8 8
Infusion or Flow Problem 8 8
Obstruction of Flow 7 7
Disconnection 7 7
Device Damaged Prior to Use 7 7
Improper or Incorrect Procedure or Method 7 7
Device Misassembled During Manufacturing /Shipping 7 7
Tear, Rip or Hole in Device Packaging 7 7
Device Contamination With Biological Material 6 6
Defective Component 6 6
Inadequacy of Device Shape and/or Size 6 6
Fire 6 6
Crack 6 6
Bent 6 6
Difficult to Open or Close 6 6
Mechanical Jam 6 6
Physical Property Issue 6 6
Noise, Audible 6 6
Partial Blockage 6 6
Cover 5 5
Syringe 5 5
Catheter 5 5
Device Or Device Fragments Location Unknown 5 5
Positioning Problem 5 5
Scratched Material 5 5
Incorrect Device Or Component Shipped 4 4
Failure to Advance 4 4
Material Rupture 4 4
Inability to Irrigate 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1410 1410
No Consequences Or Impact To Patient 1225 1225
Foreign Body In Patient 88 88
No Patient Involvement 80 80
No Information 71 71
No Code Available 68 68
No Clinical Signs, Symptoms or Conditions 49 49
Unspecified Infection 34 34
Device Embedded In Tissue or Plaque 32 32
Inflammation 28 28
Endophthalmitis 27 27
Toxicity 15 15
Tissue Damage 14 14
Hemorrhage/Bleeding 13 13
Rash 12 12
Burn(s) 10 10
Abrasion 9 9
Skin Tears 9 9
Insufficient Information 9 9
Rupture 8 8
Retinal Tear 8 8
Itching Sensation 8 8
Complaint, Ill-Defined 7 7
Reaction 7 7
Injury 6 6
Eye Injury 6 6
Exposure to Body Fluids 5 5
Intraocular Pressure, Delayed, Uncontrolled 5 5
Corneal Edema 5 5
Erythema 5 5
Laceration(s) 4 4
Retinal Detachment 4 4
Capsular Bag Tear 4 4
Pain 3 3
Visual Impairment 3 3
Local Reaction 3 3
Corneal Clouding/Hazing 3 3
Corneal Abrasion 3 3
Thrombus 3 3
Skin Irritation 3 3
Superficial (First Degree) Burn 3 3
Fluid Discharge 3 3
Swelling 2 2
Collapse 2 2
Abscess 2 2
Hematoma 2 2
Sepsis 2 2
Irritation 2 2
Hyphema 2 2
Bacterial Infection 2 2
Bone Fracture(s) 2 2
Death 2 2
Discomfort 2 2
Patient Problem/Medical Problem 2 2
Needle Stick/Puncture 2 2
Eye Burn 2 2
Burn, Thermal 2 2
Missing Value Reason 2 2
Blood Loss 1 1
Loss of Vision 1 1
Distress 1 1
Post Operative Wound Infection 1 1
Pneumothorax 1 1
Shock 1 1
Uveitis 1 1
Purulent Discharge 1 1
Edema 1 1
Abdominal Pain 1 1
Bruise/Contusion 1 1
Stroke/CVA 1 1
Hypopyon 1 1
Hypoxia 1 1
Hemolysis 1 1
Intraocular Pressure Increased 1 1
Perforation 1 1
Retinal Injury 1 1
Failure to Anastomose 1 1
Staphylococcus Aureus 1 1
Hemorrhage, Cerebral 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Bowel Burn 1 1
Loss of consciousness 1 1
Prolapse 1 1
Caustic/Chemical Burns 1 1
Vitrectomy 1 1
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 1 1
Ulceration 1 1
Perforation of Vessels 1 1
Vitreous Loss 1 1
Vitreous Hemorrhage 1 1
Discharge 1 1
Cardiac Tamponade 1 1
Multiple Organ Failure 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, LLC II Oct-09-2020
2 Alcon Research, LTD. II Aug-25-2017
3 Alcon Research, Ltd. II Oct-30-2015
4 Alcon Research, Ltd. II Jun-09-2015
5 American Contract Systems II May-29-2020
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 Centurion Medical Products Corporation II Jan-08-2015
18 Covidien LLC II Nov-08-2016
19 Custom Assemblies Inc II Aug-22-2017
20 Custom Healthcare Systems, Inc. II Jan-24-2020
21 Custom Healthcare Systems, Inc. II Oct-25-2018
22 Customed, Inc II Apr-14-2016
23 Customed, Inc II Sep-03-2015
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 II Dec-02-2015
31 DeRoyal Industries Inc II Nov-06-2015
32 DeRoyal Industries Inc II Jun-25-2015
33 Deroyal Industries, Inc. Lafollette II Feb-19-2020
34 Encore Medical, Lp II Aug-02-2018
35 Gi Supply II Mar-04-2016
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 Resource Optimization & Innovation Llc II Nov-05-2015
42 Resource Optimization & Innovation Llc II Sep-21-2015
43 Stradis Healthcare, LLC. II Jul-07-2015
44 Stryker GmbH II Mar-06-2019
45 Windstone Medical Packaging, Inc. II Nov-07-2017
46 Wright Medical Technology, Inc. II Aug-13-2020
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