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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
2021 18 18
2022 17 17
2023 23 23
2024 56 56
2025 17 17
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 21 21
Break 15 15
Appropriate Term/Code Not Available 15 15
Contamination 10 10
Packaging Problem 9 9
Component Missing 8 8
Material Puncture/Hole 4 4
Contamination /Decontamination Problem 4 4
Defective Device 3 3
Device Contamination with Chemical or Other Material 3 3
Fire 3 3
Material Fragmentation 3 3
Material Frayed 3 3
Material Split, Cut or Torn 3 3
No Apparent Adverse Event 2 2
Material Separation 2 2
Crack 2 2
Device Dislodged or Dislocated 2 2
Product Quality Problem 2 2
Material Too Rigid or Stiff 1 1
Incomplete or Missing Packaging 1 1
Connection Problem 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Mechanics Altered 1 1
Compatibility Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult or Delayed Positioning 1 1
Disconnection 1 1
Material Disintegration 1 1
Failure to Deliver Energy 1 1
Entrapment of Device 1 1
Fluid/Blood Leak 1 1
Fracture 1 1
Thermal Decomposition of Device 1 1
Complete Blockage 1 1
Unraveled Material 1 1
Use of Device Problem 1 1
Microbial Contamination of Device 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Device Emits Odor 1 1
Premature Activation 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 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 81 81
Foreign Body In Patient 29 29
Insufficient Information 26 26
Foreign Body Reaction 2 2
Superficial (First Degree) Burn 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Nausea 1 1
Fever 1 1
Laceration(s) 1 1
Pain 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems Inc II Aug-28-2025
2 American Contract Systems Inc II Mar-14-2025
3 American Contract Systems Inc. II Oct-16-2025
4 American Contract Systems, Inc. II Mar-21-2025
5 American Contract Systems, Inc. II Sep-24-2024
6 American Contract Systems, Inc. II Aug-07-2024
7 American Contract Systems, Inc. II Jan-26-2024
8 American Contract Systems, Inc. II Oct-26-2023
9 American Contract Systems, Inc. II Sep-08-2022
10 American Contract Systems, Inc. II May-06-2022
11 Cardinal Health 200, LLC II Oct-10-2023
12 DeRoyal Industries Inc II Nov-05-2024
13 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2025
14 MEDLINE INDUSTRIES, LP - Northfield II May-01-2025
15 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
16 MEDLINE INDUSTRIES, LP - Northfield I Apr-04-2025
17 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
18 MEDLINE INDUSTRIES, LP - Northfield II Mar-14-2025
19 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Nov-26-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
24 MEDLINE INDUSTRIES, LP - Northfield II Oct-10-2024
25 MEDLINE INDUSTRIES, LP - Northfield II Sep-11-2024
26 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
27 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
28 MEDLINE INDUSTRIES, LP - Northfield II Aug-22-2024
29 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
30 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
31 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
32 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
33 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
34 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
35 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
36 Medline Industries Inc II Jan-07-2021
37 Medline Industries, LP II May-07-2026
38 Medline Industries, LP II Apr-30-2026
39 Medline Industries, LP II Apr-17-2026
40 Medline Industries, LP II Apr-17-2026
41 Medline Industries, LP I Apr-07-2026
42 Medline Industries, LP II Feb-17-2026
43 Medline Industries, LP II Jan-28-2026
44 Medline Industries, LP II Jan-14-2026
45 Medline Industries, LP II Nov-14-2025
46 Medline Industries, LP I Nov-13-2025
47 ROi CPS LLC II Apr-25-2023
48 ROi CPS LLC II Nov-23-2022
49 ROi CPS LLC II Jun-08-2022
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