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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device accessories, cleaning brushes, for endoscope
Regulation Description Endoscope and accessories.
Product CodeMNL
Regulation Number 876.1500
Device Class 1

MDR Year MDR Reports MDR Events
2020 28 28
2021 68 68
2022 60 60
2023 65 65
2024 65 65
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Break 163 163
Detachment of Device or Device Component 17 17
Material Separation 16 16
Material Integrity Problem 15 15
Device Reprocessing Problem 13 13
Failure to Clean Adequately 13 13
Entrapment of Device 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Device Contaminated During Manufacture or Shipping 8 8
Failure to Disconnect 8 8
Product Quality Problem 6 6
Defective Device 6 6
Material Frayed 6 6
Inaccurate Information 5 5
Use of Device Problem 5 5
Partial Blockage 4 4
Mechanical Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Residue After Decontamination 3 3
Problem with Sterilization 3 3
Suction Problem 2 2
Contamination 2 2
Difficult to Advance 2 2
Fracture 2 2
Device Damaged by Another Device 2 2
Therapeutic or Diagnostic Output Failure 1 1
Contamination of Device Ingredient or Reagent 1 1
Fungus in Device Environment 1 1
Material Fragmentation 1 1
Microbial Contamination of Device 1 1
Physical Resistance/Sticking 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Disintegration 1 1
Naturally Worn 1 1
Improper or Incorrect Procedure or Method 1 1
Contamination /Decontamination Problem 1 1
Mechanical Jam 1 1
Degraded 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Material Too Soft/Flexible 1 1
Device Handling Problem 1 1
Device Dislodged or Dislocated 1 1
Corroded 1 1
Difficult to Remove 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 256 256
No Patient Involvement 12 12
No Consequences Or Impact To Patient 10 10
Foreign Body In Patient 5 5
Insufficient Information 5 5
No Known Impact Or Consequence To Patient 4 4
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Unspecified Tissue Injury 1 1
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Jun-02-2022
2 Mckesson Medical-Surgical Inc. Corporate Office II Mar-19-2024
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
4 Medline Industries Inc II Aug-05-2020
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