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TPLC
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show TPLC since
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Device
dislodger, stone, biliary
Product Code
LQR
Regulation Number
876.5010
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SUBSTANTIALLY EQUIVALENT - KIT
1
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT - KIT
1
SUBSTANTIALLY EQUIVALENT
3
HANGZHOU AGS MEDTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS MEDICAL SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
1
WILSON-COOK MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
WILSON-COOK MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
11
11
2018
43
43
2019
41
41
2020
51
51
2021
47
47
2022
15
15
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
117
117
Positioning Problem
25
25
Material Separation
18
18
Difficult to Remove
17
17
Adverse Event Without Identified Device or Use Problem
7
7
Material Rupture
6
6
Detachment of Device or Device Component
6
6
Difficult to Fold, Unfold or Collapse
5
5
Fracture
4
4
Material Deformation
4
4
Failure to Advance
3
3
Failure to Conduct
3
3
Entrapment of Device
2
2
Difficult to Advance
2
2
Difficult to Open or Close
2
2
Failure to Align
2
2
Mechanical Jam
2
2
Separation Problem
2
2
Failure to Deflate
1
1
Material Split, Cut or Torn
1
1
Defective Device
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Device Contamination with Chemical or Other Material
1
1
Use of Device Problem
1
1
Fitting Problem
1
1
Component Missing
1
1
Tear, Rip or Hole in Device Packaging
1
1
Material Fragmentation
1
1
Peeled/Delaminated
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
107
107
No Clinical Signs, Symptoms or Conditions
51
51
No Known Impact Or Consequence To Patient
19
19
No Code Available
17
17
Foreign Body In Patient
8
8
Device Embedded In Tissue or Plaque
5
5
Insufficient Information
3
3
No Patient Involvement
3
3
Injury
1
1
Blood Loss
1
1
Abdominal Pain
1
1
Erosion
1
1
Inflammation
1
1
Necrosis
1
1
Perforation
1
1
Jaundice
1
1
Pancreatitis
1
1
Unspecified Hepatic or Biliary Problem
1
1
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