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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 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Break 240 240
Detachment of Device or Device Component 33 33
Material Separation 21 21
Fracture 20 20
Difficult to Remove 20 20
Material Integrity Problem 18 18
Failure to Clean Adequately 16 16
Adverse Event Without Identified Device or Use Problem 16 16
Device Reprocessing Problem 15 15
Entrapment of Device 12 12
Material Fragmentation 8 8
Use of Device Problem 8 8
Device Contaminated During Manufacture or Shipping 7 7
Material Frayed 6 6
Failure to Disconnect 6 6
Device Contamination with Chemical or Other Material 6 6
Product Quality Problem 6 6
Mechanical Problem 5 5
Inaccurate Information 5 5
Defective Device 5 5
Microbial Contamination of Device 5 5
Mechanical Jam 4 4
Partial Blockage 4 4
Difficult to Insert 4 4
Degraded 4 4
Contamination 4 4
Material Twisted/Bent 2 2
Problem with Sterilization 2 2
Device Damaged by Another Device 2 2
Difficult to Advance 2 2
Improper Flow or Infusion 1 1
Material Deformation 1 1
Device Handling Problem 1 1
Obstruction of Flow 1 1
Device Emits Odor 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Residue After Decontamination 1 1
Contamination /Decontamination Problem 1 1
No Apparent Adverse Event 1 1
Suction Problem 1 1
Fungus in Device Environment 1 1
Naturally Worn 1 1
Material Too Soft/Flexible 1 1
Material Disintegration 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Physical Resistance/Sticking 1 1
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 441 441
Insufficient Information 8 10
Foreign Body In Patient 7 7
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Chemical Exposure 1 1
Eye Irritation 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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