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TPLC
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Device
endoscopic cytology brush
Regulation Description
Endoscope and accessories.
Definition
To collect cells for cytological evaluation.
Product Code
FDX
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
13
13
2021
19
19
2022
17
17
2023
17
17
2024
20
22
2025
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
44
44
Adverse Event Without Identified Device or Use Problem
18
20
Break
16
16
Mechanical Problem
7
7
Material Deformation
5
5
Retraction Problem
3
3
Material Twisted/Bent
3
3
Device Contaminated During Manufacture or Shipping
3
3
Material Fragmentation
3
3
Activation Problem
2
2
Material Separation
2
2
Contamination /Decontamination Problem
1
1
Unsealed Device Packaging
1
1
Difficult to Open or Close
1
1
Use of Device Problem
1
1
Difficult or Delayed Separation
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
47
47
Foreign Body In Patient
16
16
Insufficient Information
6
6
Hemorrhage/Bleeding
5
5
No Consequences Or Impact To Patient
4
4
Pneumothorax
4
6
Bronchial Hemorrhage
3
3
Pancreatitis
2
2
No Known Impact Or Consequence To Patient
2
2
Hypoxia
1
1
Cardiac Arrest
1
1
Device Embedded In Tissue or Plaque
1
1
No Code Available
1
1
Fever
1
1
Perforation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hobbs Medical, Inc.
II
Oct-07-2022
2
Hobbs Medical, Inc.
II
Mar-02-2022
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