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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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 18 18
Break 14 14
Appropriate Term/Code Not Available 13 13
Contamination 8 8
Component Missing 8 8
Packaging Problem 7 7
Material Puncture/Hole 4 4
Detachment of Device or Device Component 4 4
Material Separation 3 3
Material Frayed 3 3
Material Fragmentation 3 3
Defective Device 3 3
Fire 3 3
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
No Apparent Adverse Event 2 2
Connection Problem 2 2
Device Dislodged or Dislocated 2 2
Contamination /Decontamination Problem 2 2
Crack 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Emits Odor 1 1
Material Too Soft/Flexible 1 1
Device Fell 1 1
Loose or Intermittent Connection 1 1
Complete Blockage 1 1
Fluid/Blood Leak 1 1
Device Contaminated During Manufacture or Shipping 1 1
Entrapment of Device 1 1
Material Too Rigid or Stiff 1 1
Temperature Problem 1 1
Product Quality Problem 1 1
Mechanics Altered 1 1
Incomplete or Missing Packaging 1 1
Material Split, Cut or Torn 1 1
Leak/Splash 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Form Staple 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Collision 1 1
Thermal Decomposition of Device 1 1
Compatibility Problem 1 1
Use of Device Problem 1 1
Disconnection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64 64
Insufficient Information 26 26
Foreign Body In Patient 24 24
No Known Impact Or Consequence To Patient 5 5
Burn(s) 2 2
Foreign Body Reaction 2 2
Pain 1 1
Fluid Discharge 1 1
Wound Dehiscence 1 1
Obstruction/Occlusion 1 1
Laceration(s) 1 1
Nausea 1 1
Fever 1 1
No Consequences Or Impact To Patient 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1

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