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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
2016 4 4
2017 14 14
2018 8 8
2019 12 12
2020 14 14
2021 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Material Fragmentation 6 6
Device Contamination with Chemical or Other Material 6 6
Material Integrity Problem 5 5
Contamination /Decontamination Problem 4 4
Device Fell 4 4
Material Puncture/Hole 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Detachment of Device or Device Component 3 3
Detachment Of Device Component 3 3
Contamination 3 3
Flaked 3 3
Unraveled Material 3 3
Use of Device Problem 2 2
Defective Device 2 2
Device Dislodged or Dislocated 2 2
Packaging Problem 2 2
Material Separation 2 2
Material Split, Cut or Torn 2 2
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Connection Problem 1 1
Material Frayed 1 1
Difficult to Insert 1 1
Delivered as Unsterile Product 1 1
Device Emits Odor 1 1
Unintended Collision 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Fitting Problem 1 1
Component Missing 1 1
Dull, Blunt 1 1
Misfire 1 1
Split 1 1
Failure to Form Staple 1 1
Failure to Cut 1 1
Restricted Flow rate 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Component Falling 1 1
Complete Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 25 25
Insufficient Information 10 10
No Consequences Or Impact To Patient 9 9
Foreign Body In Patient 8 8
No Clinical Signs, Symptoms or Conditions 6 6
No Information 4 4
Device Embedded In Tissue or Plaque 2 2
Burn(s) 2 2
Death 1 1
Hemorrhage/Bleeding 1 1
Nausea 1 1
Wound Dehiscence 1 1
Obstruction/Occlusion 1 1
Fluid Discharge 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 Medline Industries Inc II Jan-07-2021
3 Medline Industries Inc II Feb-11-2020
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