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TPLC
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Device
stents, drains and dilators for the biliary ducts
Product Code
FGE
Regulation Number
876.5010
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOTEQUE CORPORATION
SUBSTANTIALLY EQUIVALENT
2
BOSTON SCIENTIFIC
SE - WITH LIMITATIONS
1
BOSTON SCIENTIFIC CORPORATION
SE - WITH LIMITATIONS
1
SUBSTANTIALLY EQUIVALENT
2
BRIGHTWATER MEDICAL
SUBSTANTIALLY EQUIVALENT
1
COOK IRELAND LTD
SUBSTANTIALLY EQUIVALENT
1
COOK IRELAND LTD.
SUBSTANTIALLY EQUIVALENT
1
DONGGUAN TT MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ENDO GI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ENDOGI MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ENDOGI MEDICAL, LTD.
SUBSTANTIALLY EQUIVALENT
1
SE - WITH LIMITATIONS
1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
M.I.TECH CO., LTD.
SE - WITH LIMITATIONS
2
MICRO-TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
2
S&G BIOTECH INC.
SE - WITH LIMITATIONS
1
TAEWOONG MEDICAL CO., LTD
SE - WITH LIMITATIONS
2
MDR Year
MDR Reports
MDR Events
2019
1895
1895
2020
2181
2181
2021
2297
2297
2022
1749
1749
2023
1624
1624
2024
1238
1238
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
2409
2409
Break
1040
1040
Improper or Incorrect Procedure or Method
890
890
Material Puncture/Hole
779
779
Adverse Event Without Identified Device or Use Problem
777
777
Material Deformation
672
672
Burst Container or Vessel
630
630
Off-Label Use
560
560
Detachment of Device or Device Component
464
464
Difficult to Remove
426
426
Migration
373
373
Device Dislodged or Dislocated
367
367
Activation, Positioning or Separation Problem
357
357
Difficult to Advance
304
304
Use of Device Problem
299
299
Positioning Failure
266
266
Leak/Splash
254
254
Activation Failure
247
247
Material Twisted/Bent
220
220
Fracture
217
217
Dent in Material
206
206
Premature Activation
187
187
Difficult or Delayed Positioning
154
154
Inflation Problem
152
152
Failure to Advance
143
143
Entrapment of Device
139
139
Material Integrity Problem
105
105
Material Separation
103
103
Obstruction of Flow
98
98
Positioning Problem
95
95
Physical Resistance/Sticking
88
88
Material Split, Cut or Torn
79
79
Deflation Problem
78
78
Migration or Expulsion of Device
72
72
Deformation Due to Compressive Stress
66
66
Defective Device
66
66
Mechanical Jam
62
62
Appropriate Term/Code Not Available
55
55
Stretched
51
51
Crack
50
50
Difficult or Delayed Activation
49
49
Defective Component
49
49
Fluid/Blood Leak
48
48
Device Damaged Prior to Use
46
46
Tear, Rip or Hole in Device Packaging
44
44
Unsealed Device Packaging
44
44
Malposition of Device
43
43
Retraction Problem
41
41
Device-Device Incompatibility
39
39
Failure to Deflate
32
32
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6177
6177
No Consequences Or Impact To Patient
2786
2786
No Known Impact Or Consequence To Patient
800
800
Insufficient Information
239
239
Obstruction/Occlusion
219
219
Foreign Body In Patient
164
164
Perforation
163
163
Inflammation
161
161
Hemorrhage/Bleeding
124
124
No Patient Involvement
97
97
Pancreatitis
81
81
No Code Available
81
81
Pain
76
76
Occlusion
66
66
Device Embedded In Tissue or Plaque
64
64
Abdominal Pain
55
55
Thrombosis/Thrombus
54
54
Stenosis
54
54
Vascular Dissection
49
49
Restenosis
46
46
Unspecified Infection
41
41
Patient Problem/Medical Problem
40
40
Sepsis
37
37
Hematoma
36
36
Fever
36
36
Abscess
34
34
Blood Loss
33
33
Reocclusion
30
30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
30
30
Failure of Implant
28
28
Jaundice
27
27
Thrombosis
25
25
Pseudoaneurysm
23
23
No Information
23
23
Injury
23
23
Death
21
21
Peritonitis
21
21
Bowel Perforation
18
18
Ischemia
17
17
Renal Failure
15
15
Unspecified Tissue Injury
14
14
Aneurysm
14
14
Discomfort
14
14
Rupture
14
14
Perforation of Vessels
13
13
Embolism
13
13
Vomiting
13
13
Thrombus
13
13
Unspecified Hepatic or Biliary Problem
12
12
Embolism/Embolus
12
12
Recalls
Manufacturer
Recall Class
Date Posted
1
Aomori Olympus Co., Ltd.
II
Feb-05-2021
2
Boston Scientific Corporation
II
Dec-01-2021
3
Boston Scientific Corporation
II
Oct-23-2020
4
Boston Scientific Corporation
II
Sep-12-2020
5
Boston Scientific Corporation
II
Nov-25-2019
6
Boston Scientific Corporation
II
Jul-09-2019
7
Boston Scientific Corporation
II
Mar-14-2019
8
Cook Inc.
II
Feb-28-2019
9
Cook Incorporated
II
Jun-27-2024
10
Cook Incorporated
II
Apr-12-2024
11
Cordis Corporation
II
Nov-12-2021
12
Cordis US Corp
II
Jul-11-2022
13
Hobbs Medical, Inc.
II
Oct-07-2022
14
Olympus Corporation of the Americas
II
Jan-31-2024
15
W.L. Gore & Associates, Inc.
II
Feb-22-2024
16
W.L. Gore & Associates, Inc.
II
May-14-2021
17
Wilson-Cook Medical Inc.
II
Dec-01-2023
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