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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
2018 384 384
2019 406 406
2020 767 767
2021 921 921
2022 1137 1137
2023 204 204

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 711 711
Fluid/Blood Leak 394 394
Break 269 269
Suction Failure 247 247
Adverse Event Without Identified Device or Use Problem 245 245
Leak/Splash 241 241
Contamination /Decontamination Problem 197 197
Detachment of Device or Device Component 114 114
Device Contamination with Chemical or Other Material 97 97
Inability to Irrigate 95 95
Suction Problem 84 84
Material Fragmentation 67 67
Contamination 62 62
Air/Gas in Device 61 61
Dull, Blunt 51 51
Material Twisted/Bent 51 51
Noise, Audible 47 47
Complete Blockage 45 45
No Flow 42 42
Material Puncture/Hole 41 41
Decrease in Suction 38 38
Component Missing 38 38
Therapeutic or Diagnostic Output Failure 38 38
Particulates 36 36
Infusion or Flow Problem 34 34
Appropriate Term/Code Not Available 30 30
Output Problem 29 29
Physical Resistance/Sticking 29 29
Manufacturing, Packaging or Shipping Problem 29 29
Material Integrity Problem 29 29
Fitting Problem 26 26
Obstruction of Flow 26 26
Defective Device 26 26
Difficult to Insert 24 24
Difficult to Remove 23 23
Product Quality Problem 22 22
Loose or Intermittent Connection 22 22
Material Separation 21 21
Device Displays Incorrect Message 20 20
Pressure Problem 19 19
Material Discolored 18 18
Gas/Air Leak 16 16
Material Split, Cut or Torn 16 16
Activation, Positioning or Separation Problem 15 15
Contamination of Device Ingredient or Reagent 14 14
Mechanics Altered 14 14
Insufficient Information 14 14
Material Too Soft/Flexible 14 14
Tear, Rip or Hole in Device Packaging 13 13
Device Damaged Prior to Use 13 13
Delivered as Unsterile Product 13 13
Crack 12 12
Defective Component 12 12
Device Contaminated During Manufacture or Shipping 12 12
Difficult to Open or Close 11 11
Device Operates Differently Than Expected 11 11
Use of Device Problem 11 11
Packaging Problem 11 11
Material Deformation 10 10
Failure to Infuse 9 9
Disconnection 9 9
Nonstandard Device 9 9
Mechanical Problem 9 9
Failure to Prime 9 9
Device Fell 9 9
Sharp Edges 8 8
Separation Problem 8 8
Entrapment of Device 8 8
Detachment Of Device Component 8 8
Mechanical Jam 8 8
Device Dislodged or Dislocated 7 7
Patient-Device Incompatibility 7 7
Fire 7 7
Material Frayed 7 7
Activation Problem 7 7
Material Too Rigid or Stiff 6 6
Device Slipped 6 6
Material Disintegration 6 6
Blocked Connection 6 6
Improper Flow or Infusion 6 6
Device Misassembled During Manufacturing /Shipping 5 5
Failure to Advance 5 5
Collapse 5 5
Loss of or Failure to Bond 5 5
Reflux within Device 5 5
Hole In Material 5 5
Energy Output Problem 5 5
No Device Output 5 5
Positioning Problem 5 5
Unintended Movement 4 4
Kinked 4 4
Gas Output Problem 4 4
Device Alarm System 4 4
Degraded 4 4
Fracture 4 4
Electrical /Electronic Property Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Structural Problem 4 4
Sparking 4 4
Vibration 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2090 2090
No Known Impact Or Consequence To Patient 553 553
No Consequences Or Impact To Patient 476 476
Insufficient Information 139 139
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 71 71
Foreign Body In Patient 62 62
Toxic Anterior Segment Syndrome (TASS) 56 56
Endophthalmitis 56 56
No Patient Involvement 52 52
Inflammation 44 44
Unspecified Infection 38 38
Uveitis 37 37
Capsular Bag Tear 26 26
No Information 25 25
No Code Available 19 19
Retinal Tear 19 19
Corneal Edema 18 18
Hemorrhage/Bleeding 17 17
Device Embedded In Tissue or Plaque 15 15
Eye Burn 15 15
Intraocular Pressure Decreased 14 14
Retinal Detachment 14 14
Retinal Injury 13 13
Burn(s) 11 11
Blurred Vision 10 10
Eye Pain 10 10
Loss of Vision 9 9
Vitritis 9 9
Hypopyon 9 9
Conjunctivitis 8 8
Intraocular Pressure Increased 7 7
Vitreous Hemorrhage 6 6
Eye Injury 6 6
Injury 6 6
Skin Tears 5 5
Unspecified Eye / Vision Problem 5 5
Corneal Clouding/Hazing 5 5
Corneal Abrasion 5 5
Rash 5 5
Visual Disturbances 4 4
Vitreous Loss 4 4
Corneal Ulcer 4 4
Bacterial Infection 4 4
Fluid Discharge 4 4
Fibrosis 3 3
Burn, Thermal 3 3
Abrasion 3 3
Hyphema 3 3
Visual Impairment 3 3
Tissue Damage 3 3
Local Reaction 3 3
Pain 3 3
Itching Sensation 3 3
Laceration(s) 3 3
Optical Nerve Damage 2 2
Keratitis 2 2
Red Eye(s) 2 2
Thrombus 2 2
Sepsis 2 2
Rupture 2 2
Hyperemia 2 2
Hypersensitivity/Allergic reaction 2 2
Abscess 2 2
Death 2 2
Discomfort 2 2
Needle Stick/Puncture 2 2
Prolapse 2 2
Missing Value Reason 2 2
Zonular Dehiscence 2 2
Multiple Organ Failure 1 1
Muscle Hypotonia 1 1
Skin Inflammation/ Irritation 1 1
Drug Resistant Bacterial Infection 1 1
Partial thickness (Second Degree) Burn 1 1
Patient Problem/Medical Problem 1 1
Complaint, Ill-Defined 1 1
Reaction 1 1
Loss of consciousness 1 1
Vitreous Detachment 1 1
Post Operative Wound Infection 1 1
Caustic/Chemical Burns 1 1
Chemical Exposure 1 1
Vitrectomy 1 1
Superficial (First Degree) Burn 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
Abdominal Pain 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Hematoma 1 1
Hemolysis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alcon Research, LLC II Dec-01-2022
2 Alcon Research, LLC II Jul-12-2022
3 Alcon Research, LLC II Apr-01-2021
4 Alcon Research, LLC II Oct-09-2020
5 American Contract Systems II May-29-2020
6 American Contract Systems, Inc. II Nov-22-2022
7 American Contract Systems, Inc. II Sep-08-2022
8 Avid Medical, Inc. I Jun-04-2021
9 Avid Medical, Inc. II Mar-19-2020
10 Avid Medical, Inc. II Feb-28-2018
11 Avid Medical, Inc. II Feb-09-2018
12 Cardinal Health 200, LLC II Feb-04-2020
13 Cardinal Health 200, LLC II Feb-03-2020
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 Healthcare Systems, Inc. II Jan-24-2020
19 Custom Healthcare Systems, Inc. II Oct-25-2018
20 DeRoyal Industries Inc II Jan-09-2023
21 DeRoyal Industries Inc II Jan-05-2023
22 DeRoyal Industries Inc II Dec-15-2022
23 DeRoyal Industries Inc II Aug-31-2022
24 DeRoyal Industries Inc II Apr-06-2022
25 DeRoyal Industries Inc I Jun-10-2021
26 DeRoyal Industries Inc II Feb-19-2021
27 DeRoyal Industries Inc II Jul-16-2019
28 DeRoyal Industries Inc II Feb-16-2018
29 DeRoyal Industries Inc II Jan-12-2018
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 - Northfield II Feb-23-2023
34 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
35 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
36 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
37 MEDLINE INDUSTRIES, LP - Northfield II Nov-01-2022
38 MEDLINE INDUSTRIES, LP - Northfield II Oct-21-2022
39 MEDLINE INDUSTRIES, LP - Northfield II Oct-20-2022
40 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
41 Medical Action Industries, Inc. 306 II Jun-24-2021
42 Medline Industries Inc II Dec-10-2021
43 Medline Industries Inc II Jun-09-2021
44 Medline Industries Inc II Jan-07-2021
45 Medline Industries Inc II May-15-2020
46 Medline Industries Inc II Mar-20-2020
47 ROi CPS LLC II Nov-23-2022
48 ROi CPS LLC II Jun-09-2022
49 ROi CPS LLC II Nov-18-2021
50 ROi CPS LLC II Jan-30-2020
51 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
52 Stryker GmbH II Mar-06-2019
53 Wright Medical Technology, Inc. II Aug-13-2020
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