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TPLC
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Device
accessories, cleaning brushes, for endoscope
Regulation Description
Endoscope and accessories.
Product Code
MNL
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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