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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
2021 68 68
2022 60 62
2023 65 65
2024 66 66
2025 142 142

Device Problems MDRs with this Device Problem Events in those MDRs
Break 221 221
Detachment of Device or Device Component 33 33
Material Separation 20 20
Material Integrity Problem 16 16
Failure to Clean Adequately 16 18
Adverse Event Without Identified Device or Use Problem 15 15
Device Reprocessing Problem 13 13
Entrapment of Device 12 12
Difficult to Remove 11 11
Use of Device Problem 8 8
Device Contaminated During Manufacture or Shipping 7 7
Fracture 7 7
Failure to Disconnect 6 6
Product Quality Problem 6 6
Material Frayed 6 6
Defective Device 5 5
Device Contamination with Chemical or Other Material 5 5
Inaccurate Information 5 5
Material Fragmentation 4 4
Partial Blockage 4 4
Mechanical Problem 4 4
Mechanical Jam 4 4
Contamination 3 3
Microbial Contamination of Device 2 2
Contamination /Decontamination Problem 2 2
Degraded 2 2
Difficult to Insert 2 2
Problem with Sterilization 2 2
Device Damaged by Another Device 2 2
Difficult to Advance 2 2
Residue After Decontamination 2 2
Suction Problem 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Improper Flow or Infusion 1 1
Delivered as Unsterile Product 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Device Emits Odor 1 1
Insufficient Information 1 1
Contamination of Device Ingredient or Reagent 1 1
Material Disintegration 1 1
No Apparent Adverse Event 1 1
Physical Resistance/Sticking 1 1
Device Dislodged or Dislocated 1 1
Fungus in Device Environment 1 1
Naturally Worn 1 1
Material Too Soft/Flexible 1 1
Corroded 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 384 384
Foreign Body In Patient 6 6
Insufficient Information 6 8
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Chemical Exposure 1 1
No Patient Involvement 1 1
Laceration(s) 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Healthmark Industries Co., Inc. II Jun-05-2025
2 MEDLINE INDUSTRIES, LP - Northfield II Jun-02-2022
3 Mckesson Medical-Surgical Inc. Corporate Office II Mar-19-2024
4 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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