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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
2026 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Break 237 237
Detachment of Device or Device Component 34 34
Fracture 20 20
Material Separation 20 20
Difficult to Remove 19 19
Material Integrity Problem 18 18
Device Reprocessing Problem 17 17
Failure to Clean Adequately 17 19
Adverse Event Without Identified Device or Use Problem 16 16
Entrapment of Device 12 12
Material Fragmentation 10 10
Use of Device Problem 8 8
Device Contaminated During Manufacture or Shipping 7 7
Material Frayed 6 6
Failure to Disconnect 6 6
Product Quality Problem 6 6
Mechanical Problem 5 5
Inaccurate Information 5 5
Defective Device 5 5
Device Contamination with Chemical or Other Material 5 5
Microbial Contamination of Device 5 5
Degraded 5 5
Mechanical Jam 4 4
Partial Blockage 4 4
Contamination 4 4
Difficult to Insert 3 3
Material Twisted/Bent 2 2
Problem with Sterilization 2 2
Device Damaged by Another Device 2 2
Contamination /Decontamination Problem 2 2
Residue After Decontamination 2 2
Device Dislodged or Dislocated 2 2
Difficult to Advance 2 2
Suction Problem 2 2
Improper Flow or Infusion 1 1
Obstruction of Flow 1 1
Delivered as Unsterile Product 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Emits Odor 1 1
Contamination of Device Ingredient or Reagent 1 1
Manufacturing, Packaging or Shipping Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Fungus in Device Environment 1 1
Naturally Worn 1 1
Material Too Soft/Flexible 1 1
Material Disintegration 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 432 432
Foreign Body In Patient 7 7
Insufficient Information 7 9
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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