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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 66 66
2025 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Break 195 195
Detachment of Device or Device Component 22 22
Material Integrity Problem 16 16
Material Separation 16 16
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
Use of Device Problem 7 7
Material Frayed 6 6
Defective Device 6 6
Product Quality Problem 6 6
Inaccurate Information 5 5
Mechanical Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Partial Blockage 4 4
Difficult to Advance 3 3
Contamination 3 3
Fracture 3 3
Residue After Decontamination 3 3
Problem with Sterilization 3 3
Suction Problem 2 2
Device Damaged by Another Device 2 2
Microbial Contamination of Device 2 2
Difficult to Remove 2 2
Improper Flow or Infusion 1 1
Device Handling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Emits Odor 1 1
Difficult to Insert 1 1
Material Fragmentation 1 1
Degraded 1 1
Contamination of Device Ingredient or Reagent 1 1
Contamination /Decontamination Problem 1 1
No Apparent Adverse Event 1 1
Device Dislodged or Dislocated 1 1
Therapeutic or Diagnostic Output Failure 1 1
Manufacturing, Packaging or Shipping Problem 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
Improper or Incorrect Procedure or Method 1 1
Physical Resistance/Sticking 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 299 299
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
Chemical Exposure 1 1
Laceration(s) 1 1
Unspecified Tissue Injury 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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