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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
2018 8 8
2019 12 12
2020 14 14
2021 18 18
2022 17 17
2023 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11 11
Packaging Problem 7 7
Material Integrity Problem 6 6
Component Missing 6 6
Contamination 4 4
Material Fragmentation 4 4
Device Contamination with Chemical or Other Material 4 4
Contamination /Decontamination Problem 4 4
Device Fell 4 4
Material Separation 3 3
Unraveled Material 3 3
Detachment of Device or Device Component 3 3
Defective Device 3 3
Material Frayed 3 3
Material Puncture/Hole 3 3
Fire 2 2
Device Dislodged or Dislocated 2 2
Material Split, Cut or Torn 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Appropriate Term/Code Not Available 2 2
Material Too Soft/Flexible 1 1
Device Markings/Labelling Problem 1 1
Use of Device Problem 1 1
Connection Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanics Altered 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Fluid/Blood Leak 1 1
Product Quality Problem 1 1
Material Too Rigid or Stiff 1 1
Incomplete or Missing Packaging 1 1
Dull, Blunt 1 1
Misfire 1 1
Failure to Form Staple 1 1
Failure to Cut 1 1
Loose or Intermittent Connection 1 1
Device Emits Odor 1 1
Unintended Collision 1 1
Disconnection 1 1
Entrapment of Device 1 1
Thermal Decomposition of Device 1 1
Complete Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
Insufficient Information 19 19
No Known Impact Or Consequence To Patient 18 18
Foreign Body In Patient 15 15
No Consequences Or Impact To Patient 4 4
Foreign Body Reaction 2 2
Burn(s) 2 2
No Information 2 2
Partial thickness (Second Degree) Burn 1 1
Fever 1 1
Wound Dehiscence 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 Oct-26-2023
3 American Contract Systems, Inc. II Sep-08-2022
4 American Contract Systems, Inc. II May-06-2022
5 Cardinal Health 200, LLC II Oct-10-2023
6 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
9 MEDLINE INDUSTRIES, LP - Northfield II Jan-27-2023
10 MEDLINE INDUSTRIES, LP - SPT II Jul-27-2022
11 Medline Industries Inc II Jan-07-2021
12 Medline Industries Inc II Feb-11-2020
13 ROi CPS LLC II Apr-25-2023
14 ROi CPS LLC II Nov-23-2022
15 ROi CPS LLC II Jun-08-2022
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