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TPLC
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Device
endoscopic cytology brush
Definition
To collect cells for cytological evaluation.
Product Code
FDX
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
MICRO-TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
UNITED STATES ENDOSCOPY GROUP, INC.
SUBSTANTIALLY EQUIVALENT
2
WILSON-COOK MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
WILSON-COOK MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
SUBSTANTIALLY EQUIVALENT
1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
1. K220063
Single Use Cytology Brush
MDR Year
MDR Reports
MDR Events
2014
61
61
2015
62
62
2016
45
45
2017
44
44
2018
48
48
2019
67
67
2020
13
13
2021
19
19
2022
17
17
2023
17
17
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
137
137
Bent
57
57
Detachment of Device or Device Component
46
46
Detachment Of Device Component
46
46
Material Twisted/Bent
40
40
Adverse Event Without Identified Device or Use Problem
34
34
Mechanical Problem
22
22
Retraction Problem
22
22
Patient-Device Incompatibility
14
14
Material Deformation
10
10
Material Separation
8
8
Insufficient Information
5
5
Device Contamination with Chemical or Other Material
4
4
Difficult to Advance
4
4
Device Contaminated During Manufacture or Shipping
3
3
Use of Device Problem
3
3
Material Fragmentation
3
3
Material Frayed
2
2
Defective Device
2
2
Activation Problem
2
2
Device Dislodged or Dislocated
2
2
Difficult or Delayed Separation
1
1
Contamination /Decontamination Problem
1
1
Difficult to Open or Close
1
1
Device Operates Differently Than Expected
1
1
Material Integrity Problem
1
1
Material Protrusion/Extrusion
1
1
Appropriate Term/Code Not Available
1
1
Device Handling Problem
1
1
Positioning Problem
1
1
Material Rupture
1
1
Component Missing
1
1
Unraveled Material
1
1
Migration or Expulsion of Device
1
1
Unsealed Device Packaging
1
1
Peeled/Delaminated
1
1
Component Falling
1
1
Decrease in Suction
1
1
Fracture
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
255
255
No Known Impact Or Consequence To Patient
41
41
No Clinical Signs, Symptoms or Conditions
38
38
Foreign Body In Patient
16
16
Pneumothorax
16
16
Insufficient Information
6
6
No Information
5
5
Death
5
5
Hemorrhage/Bleeding
5
5
Inflammation
3
3
Sepsis
3
3
Bronchial Hemorrhage
3
3
Pancreatitis
2
2
No Code Available
2
2
Device Embedded In Tissue or Plaque
2
2
Hemoptysis
2
2
Blood Loss
2
2
Complaint, Ill-Defined
1
1
Injury
1
1
Perforation
1
1
Unspecified Infection
1
1
Dyspnea
1
1
Fever
1
1
Anemia
1
1
Cardiac Arrest
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hobbs Medical, Inc.
II
Oct-07-2022
2
Hobbs Medical, Inc.
II
Mar-02-2022
3
Hobbs Medical, Inc.
II
Jun-01-2018
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