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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laparoscopy kit
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 CodeFDE
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2019 12 12
2020 14 14
2021 18 18
2022 17 17
2023 23 23
2024 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Break 15 15
Material Integrity Problem 12 12
Component Missing 8 8
Packaging Problem 7 7
Contamination 6 6
Material Puncture/Hole 5 5
Contamination /Decontamination Problem 5 5
Appropriate Term/Code Not Available 5 5
Detachment of Device or Device Component 4 4
Device Contamination with Chemical or Other Material 4 4
Material Fragmentation 4 4
Material Separation 3 3
Defective Device 3 3
Device Fell 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Material Split, Cut or Torn 2 2
Device Dislodged or Dislocated 2 2
Connection Problem 2 2
Unraveled Material 2 2
Material Frayed 2 2
Fire 2 2
Fluid/Blood Leak 1 1
Thermal Decomposition of Device 1 1
Complete Blockage 1 1
Crack 1 1
Disconnection 1 1
Entrapment of Device 1 1
Loose or Intermittent Connection 1 1
Device Emits Odor 1 1
Unintended Collision 1 1
Use of Device Problem 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Incomplete or Missing Packaging 1 1
Failure to Form Staple 1 1
Device Markings/Labelling Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanics Altered 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
Insufficient Information 23 23
Foreign Body In Patient 18 18
No Known Impact Or Consequence To Patient 13 13
No Consequences Or Impact To Patient 3 3
Foreign Body Reaction 2 2
Burn(s) 2 2
Fever 1 1
Wound Dehiscence 1 1
Partial thickness (Second Degree) Burn 1 1
No Information 1 1
Laceration(s) 1 1
Nausea 1 1
Pain 1 1
Obstruction/Occlusion 1 1
Superficial (First Degree) Burn 1 1
Fluid Discharge 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Jan-26-2024
3 American Contract Systems, Inc. II Oct-26-2023
4 American Contract Systems, Inc. II Sep-08-2022
5 American Contract Systems, Inc. II May-06-2022
6 Cardinal Health 200, LLC II Oct-10-2023
7 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
12 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
13 Medline Industries Inc II Jan-07-2021
14 Medline Industries Inc II Feb-11-2020
15 ROi CPS LLC II Apr-25-2023
16 ROi CPS LLC II Nov-23-2022
17 ROi CPS LLC II Jun-08-2022
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