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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
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


Premarket Reviews
ManufacturerDecision
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 523 523
2018 384 384
2019 406 406
2020 767 767
2021 921 921
2022 725 725

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 568 568
Leak/Splash 451 451
Fluid Leak 407 407
Break 253 253
Adverse Event Without Identified Device or Use Problem 224 224
Suction Failure 170 170
Contamination /Decontamination Problem 164 164
Device Contamination with Chemical or Other Material 125 125
Detachment of Device or Device Component 100 100
Inability to Irrigate 74 74
Material Fragmentation 72 72
Suction Problem 67 67
Air/Gas in Device 56 56
Contamination 54 54
Dull, Blunt 53 53
Material Puncture/Hole 40 40
Component Missing 38 38
Therapeutic or Diagnostic Output Failure 38 38
Material Integrity Problem 38 38
Noise, Audible 31 31
Decrease in Suction 30 30
Complete Blockage 30 30
Manufacturing, Packaging or Shipping Problem 29 29
Physical Resistance/Sticking 29 29
No Flow 29 29
Output Problem 28 28
Infusion or Flow Problem 28 28
Detachment Of Device Component 28 28
Particulates 28 28
Material Twisted/Bent 27 27
Loose or Intermittent Connection 25 25
Difficult to Insert 25 25
Obstruction of Flow 25 25
Device Operates Differently Than Expected 24 24
Fitting Problem 22 22
Product Quality Problem 22 22
Difficult to Remove 22 22
Material Discolored 22 22
Material Separation 21 21
Pressure Problem 20 20
Insufficient Information 19 19
Appropriate Term/Code Not Available 19 19
Defective Device 18 18
Contamination of Device Ingredient or Reagent 16 16
Gas Leak 16 16
Device Contaminated During Manufacture or Shipping 15 15
Activation, Positioning or SeparationProblem 15 15
Material Split, Cut or Torn 15 15
Mechanics Altered 14 14
Material Too Soft/Flexible 14 14
Device Displays Incorrect Message 14 14
Tear, Rip or Hole in Device Packaging 14 14
Material Frayed 14 14
Delivered as Unsterile Product 13 13
Packaging Problem 13 13
Mechanical Problem 12 12
Patient-Device Incompatibility 12 12
Device Dislodged or Dislocated 12 12
Entrapment of Device 11 11
Crack 10 10
Difficult to Open or Close 10 10
Device Damaged Prior to Use 10 10
Use of Device Problem 10 10
Device Slipped 9 9
Material Deformation 9 9
Nonstandard Device 9 9
Sticking 8 8
Mechanical Jam 8 8
Device Fell 8 8
Separation Problem 8 8
Activation Problem 7 7
Material Too Rigid or Stiff 7 7
Hole In Material 7 7
Failure to Prime 7 7
Fire 7 7
Disconnection 7 7
Material Disintegration 6 6
Defective Component 6 6
Blocked Connection 6 6
Positioning Problem 6 6
Improper Flow or Infusion 5 5
Device Packaging Compromised 5 5
Failure to Infuse 5 5
Failure to Advance 5 5
Degraded 5 5
Collapse 5 5
Loss of or Failure to Bond 5 5
Reflux within Device 5 5
Energy Output Problem 5 5
Kinked 5 5
Fracture 4 4
No Device Output 4 4
Component Falling 4 4
Device Alarm System 4 4
Electrical /Electronic Property Problem 4 4
Structural Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Sparking 4 4
Device Contamination With Biological Material 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1533 1533
No Known Impact Or Consequence To Patient 855 855
No Consequences Or Impact To Patient 617 617
Insufficient Information 135 135
Foreign Body In Patient 72 72
No Patient Involvement 65 65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 56 56
Endophthalmitis 48 48
No Information 42 42
Inflammation 40 40
Unspecified Infection 39 39
Toxic Anterior Segment Syndrome (TASS) 38 38
Uveitis 33 33
No Code Available 27 27
Device Embedded In Tissue or Plaque 22 22
Capsular Bag Tear 22 22
Hemorrhage/Bleeding 16 16
Corneal Edema 15 15
Retinal Tear 15 15
Eye Burn 13 13
Retinal Detachment 12 12
Retinal Injury 11 11
Burn(s) 11 11
Intraocular Pressure Decreased 10 10
Vitritis 9 9
Rash 9 9
Loss of Vision 8 8
Hypopyon 7 7
Eye Injury 7 7
Injury 7 7
Eye Pain 7 7
Blurred Vision 6 6
Intraocular Pressure Increased 5 5
Abrasion 5 5
Conjunctivitis 5 5
Corneal Abrasion 5 5
Corneal Ulcer 4 4
Bacterial Infection 4 4
Corneal Clouding/Hazing 4 4
Itching Sensation 4 4
Laceration(s) 4 4
Tissue Damage 4 4
Vitreous Hemorrhage 4 4
Complaint, Ill-Defined 4 4
Unspecified Eye / Vision Problem 4 4
Fluid Discharge 4 4
Skin Tears 4 4
Needle Stick/Puncture 3 3
Burn, Thermal 3 3
Fibrosis 3 3
Vitreous Loss 3 3
Pain 3 3
Local Reaction 3 3
Sepsis 2 2
Optical Nerve Damage 2 2
Keratitis 2 2
Rupture 2 2
Distress 2 2
Thrombus 2 2
Visual Impairment 2 2
Visual Disturbances 2 2
Bone Fracture(s) 2 2
Hyphema 2 2
Hyperemia 2 2
Hypersensitivity/Allergic reaction 2 2
Abscess 2 2
Death 2 2
Zonular Dehiscence 2 2
Missing Value Reason 2 2
Prolapse 2 2
Reaction 2 2
Loss of consciousness 1 1
Vitreous Detachment 1 1
Post Operative Wound Infection 1 1
Caustic/Chemical Burns 1 1
Vitrectomy 1 1
Superficial (First Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Multiple Organ Failure 1 1
Partial thickness (Second Degree) Burn 1 1
Muscle Hypotonia 1 1
Drug Resistant Bacterial Infection 1 1
Purulent Discharge 1 1
Edema 1 1
Crushing Injury 1 1
Corneal Scar 1 1
Exposure to Body Fluids 1 1
Bowel Burn 1 1
Calcium Deposits/Calcification 1 1
Stroke/CVA 1 1
Chemosis 1 1
High Blood Pressure/ Hypertension 1 1
Hemorrhage, Cerebral 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Abdominal Pain 1 1
Hematoma 1 1
Hemolysis 1 1
Vitreous Floaters 1 1
Foreign Body Sensation in Eye 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, LLC II Jul-12-2022
2 Alcon Research, LLC II Apr-01-2021
3 Alcon Research, LLC II Oct-09-2020
4 Alcon Research, LTD. II Aug-25-2017
5 American Contract Systems II May-29-2020
6 American Contract Systems, Inc. II Sep-08-2022
7 Avid Medical, Inc. I Jun-04-2021
8 Avid Medical, Inc. II Mar-19-2020
9 Avid Medical, Inc. II Feb-28-2018
10 Avid Medical, Inc. II Feb-09-2018
11 Cardinal Health 200, LLC II Feb-04-2020
12 Cardinal Health 200, LLC II Feb-03-2020
13 Cardinal Health 200, LLC II Aug-14-2017
14 Cardinal Health Inc. II Jan-09-2019
15 Centurion Medical Products Corporation II Feb-05-2020
16 Centurion Medical Products Corporation II Nov-06-2019
17 Centurion Medical Products Corporation II Oct-31-2019
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 DeRoyal Industries Inc II Aug-31-2022
22 DeRoyal Industries Inc II Apr-06-2022
23 DeRoyal Industries Inc I Jun-10-2021
24 DeRoyal Industries Inc II Feb-19-2021
25 DeRoyal Industries Inc II Jul-16-2019
26 DeRoyal Industries Inc II Feb-16-2018
27 DeRoyal Industries Inc II Jan-12-2018
28 DeRoyal Industries Inc II Dec-06-2017
29 DeRoyal Industries Inc III Feb-23-2017
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 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
34 Medical Action Industries, Inc. 306 II Jun-24-2021
35 Medline Industries Inc II Dec-10-2021
36 Medline Industries Inc II Jun-09-2021
37 Medline Industries Inc II Jan-07-2021
38 Medline Industries Inc II May-15-2020
39 Medline Industries Inc II Mar-20-2020
40 ROi CPS LLC II Jun-09-2022
41 ROi CPS LLC II Nov-18-2021
42 ROi CPS LLC II Jan-30-2020
43 Resource Optimization & Innovation Llc II Nov-21-2017
44 Resource Optimization & Innovation Llc II Mar-24-2017
45 Stryker GmbH II Mar-06-2019
46 Windstone Medical Packaging, Inc. II Nov-07-2017
47 Wright Medical Technology, Inc. II Aug-13-2020
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