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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 208 208

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 31 31
Material Integrity Problem 27 27
Component Missing 24 24
Unsealed Device Packaging 22 22
Break 18 18
Material Frayed 17 17
Appropriate Device Problem Term/Code Not Available 15 15
Premature Activation 10 10
Material Puncture/Hole 10 10
Material Disintegration 8 8
Dull, Blunt 7 7
Corroded 7 7
Material Fragmentation 7 7
Detachment of Device or Device Component 6 6
Material Separation 6 6
Contamination 6 6
Leak/Splash 5 5
Material Split, Cut or Torn 5 5
Adhesive Too Strong 5 5
Contamination /Decontamination Problem 4 4
Extra Components 3 3
Electrical /Electronic Property Problem 3 3
Fire 3 3
Unraveled Material 3 3
No Device Output 2 2
Loss of or Failure to Bond 2 2
Self-Activation or Keying 2 2
Melted 2 2
No Apparent Adverse Event 2 2
Product Quality Problem 2 2
Particulates 2 2
Insufficient Device Problem Information 2 2
Expiration Date Error 2 2
Crack 2 2
Sparking 2 2
Material Discolored 1 1
Thermal Decomposition of Device 1 1
Lack of Effect 1 1
Difficult or Delayed Positioning 1 1
Material Deformation 1 1
Decoupling 1 1
Smoking 1 1
Failure to Sense 1 1
Tear, Rip or Hole in Device Packaging 1 1
Collapse 1 1
Device Contamination with Chemical or Other Material 1 1
Device Markings/Labelling Problem 1 1
Peeled/Delaminated 1 1
Fracture 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 268 268
Foreign Body In Patient 29 29
Insufficient Information 29 29
Burn(s) 5 5
Foreign Body Reaction 2 2
Superficial (First Degree) Burn 1 1
Nausea 1 1
Fever 1 1
Exposure to Body Fluids 1 1
Laceration(s) 1 1
Pain 1 1
Partial thickness (Second Degree) Burn 1 1
Bruise/Contusion 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 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 Sep-03-2026
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, LP II Aug-31-2026
39 Medline Industries, LP II Aug-26-2026
40 Medline Industries, LP II Jun-25-2026
41 Medline Industries, LP II Jun-17-2026
42 Medline Industries, LP II Jun-12-2026
43 Medline Industries, LP II May-07-2026
44 Medline Industries, LP II Apr-30-2026
45 Medline Industries, LP II Apr-17-2026
46 Medline Industries, LP II Apr-17-2026
47 Medline Industries, LP I Apr-07-2026
48 Medline Industries, LP II Feb-17-2026
49 Medline Industries, LP II Jan-28-2026
50 Medline Industries, LP II Jan-14-2026
51 Medline Industries, LP II Nov-14-2025
52 Medline Industries, LP I Nov-13-2025
53 ROi CPS LLC II Apr-25-2023
54 ROi CPS LLC II Nov-23-2022
55 ROi CPS LLC II Jun-08-2022
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