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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2020 14 14
2021 18 18
2022 17 17
2023 23 23
2024 56 56
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 19 19
Break 15 15
Appropriate Term/Code Not Available 15 15
Contamination 9 9
Component Missing 8 8
Packaging Problem 7 7
Material Puncture/Hole 4 4
Detachment of Device or Device Component 4 4
Material Separation 4 4
Material Frayed 3 3
Fire 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Material Fragmentation 3 3
Connection Problem 2 2
Crack 2 2
Device Markings/Labelling Problem 2 2
Device Dislodged or Dislocated 2 2
No Apparent Adverse Event 2 2
Device Contamination with Chemical or Other Material 2 2
Product Quality Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Temperature Problem 1 1
Unintended Collision 1 1
Fluid/Blood Leak 1 1
Loose or Intermittent Connection 1 1
Material Too Soft/Flexible 1 1
Failure to Form Staple 1 1
Fracture 1 1
Device Emits Odor 1 1
Difficult or Delayed Positioning 1 1
Mechanics Altered 1 1
Thermal Decomposition of Device 1 1
Use of Device Problem 1 1
Material Too Rigid or Stiff 1 1
Unraveled Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Fell 1 1
Complete Blockage 1 1
Incomplete or Missing Packaging 1 1
Entrapment of Device 1 1
Material Split, Cut or Torn 1 1
Device Contaminated During Manufacture or Shipping 1 1
Compatibility Problem 1 1
Leak/Splash 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 68 68
Foreign Body In Patient 29 29
Insufficient Information 27 27
No Known Impact Or Consequence To Patient 5 5
Foreign Body Reaction 2 2
Burn(s) 2 2
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Wound Dehiscence 1 1
Nausea 1 1
Obstruction/Occlusion 1 1
Fever 1 1
Laceration(s) 1 1
Pain 1 1
Fluid Discharge 1 1
Partial thickness (Second Degree) Burn 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems Inc II Aug-28-2025
3 American Contract Systems Inc II Mar-14-2025
4 American Contract Systems Inc. II Oct-16-2025
5 American Contract Systems, Inc. II Mar-21-2025
6 American Contract Systems, Inc. II Sep-24-2024
7 American Contract Systems, Inc. II Aug-07-2024
8 American Contract Systems, Inc. II Jan-26-2024
9 American Contract Systems, Inc. II Oct-26-2023
10 American Contract Systems, Inc. II Sep-08-2022
11 American Contract Systems, Inc. II May-06-2022
12 Cardinal Health 200, LLC II Oct-10-2023
13 DeRoyal Industries Inc II Nov-05-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2025
15 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
16 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
17 MEDLINE INDUSTRIES, LP - Northfield I Apr-04-2025
18 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
19 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
20 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Nov-26-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
24 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
25 MEDLINE INDUSTRIES, LP - Northfield II Oct-10-2024
26 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
27 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
28 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
29 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
30 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
31 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
32 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
33 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
34 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
35 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
36 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
37 Medline Industries Inc II Jan-07-2021
38 Medline Industries Inc II Feb-11-2020
39 Medline Industries, LP II Nov-14-2025
40 Medline Industries, LP I Nov-13-2025
41 ROi CPS LLC II Apr-25-2023
42 ROi CPS LLC II Nov-23-2022
43 ROi CPS LLC II Jun-08-2022
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