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TPLC
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Device
endoscopic guidewire, gastroenterology-urology
Definition
To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
Product Code
OCY
Regulation Number
876.1500
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORP.
SUBSTANTIALLY EQUIVALENT
1
COLOPLAST A/S
SUBSTANTIALLY EQUIVALENT
2
LAKE REGION MEDICAL
SUBSTANTIALLY EQUIVALENT
3
MEDI-GLOBE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NEOMETRICS, INC.
SUBSTANTIALLY EQUIVALENT
3
TERUMO CORP.
SUBSTANTIALLY EQUIVALENT
1
TERUMO MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
WILSON-COOK MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
WILSON-COOK MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
XENOLITH MEDICAL
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
51
51
2015
283
283
2016
158
158
2017
85
85
2018
101
101
2019
102
102
2020
128
128
2021
94
94
2022
134
134
2023
115
115
2024
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
Peeled/Delaminated
406
406
Detachment Of Device Component
378
378
Material Separation
110
110
Break
102
102
Adverse Event Without Identified Device or Use Problem
61
61
Detachment of Device or Device Component
31
31
Fracture
27
27
Positioning Problem
23
23
Migration or Expulsion of Device
20
20
Material Fragmentation
19
19
Material Twisted/Bent
18
18
Material Deformation
18
18
Unraveled Material
17
17
Improper or Incorrect Procedure or Method
11
11
Difficult to Advance
11
11
Deformation Due to Compressive Stress
10
10
Entrapment of Device
10
10
Flaked
9
9
Device Damaged by Another Device
9
9
Appropriate Term/Code Not Available
9
9
Off-Label Use
8
8
Difficult to Remove
7
7
Positioning Failure
7
7
Material Frayed
7
7
Insufficient Information
7
7
Material Integrity Problem
6
6
Use of Device Problem
6
6
Device Damaged Prior to Use
5
5
Material Too Rigid or Stiff
5
5
Bent
5
5
Defective Device
5
5
Physical Resistance/Sticking
5
5
Device-Device Incompatibility
4
4
Device Operates Differently Than Expected
4
4
Device Dislodged or Dislocated
4
4
Device Contamination with Chemical or Other Material
4
4
Device Contaminated During Manufacture or Shipping
4
4
Material Disintegration
4
4
Difficult to Insert
4
4
Unsealed Device Packaging
4
4
Microbial Contamination of Device
4
4
Material Protrusion/Extrusion
3
3
Contamination /Decontamination Problem
3
3
Failure to Advance
2
2
No Apparent Adverse Event
2
2
Mechanical Jam
2
2
Scratched Material
2
2
Migration
2
2
Material Split, Cut or Torn
2
2
Cut In Material
2
2
Particulates
2
2
Accessory Incompatible
2
2
Component Falling
1
1
Crack
1
1
Loose or Intermittent Connection
1
1
Delivered as Unsterile Product
1
1
Image Display Error/Artifact
1
1
Product Quality Problem
1
1
Uncoiled
1
1
Structural Problem
1
1
Component Missing
1
1
Wire(s), breakage of
1
1
Tear, Rip or Hole in Device Packaging
1
1
Inadequate Lubrication
1
1
Torn Material
1
1
Physical Resistance
1
1
Device Packaging Compromised
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
687
687
No Clinical Signs, Symptoms or Conditions
287
287
No Known Impact Or Consequence To Patient
100
100
Foreign Body In Patient
73
73
Device Embedded In Tissue or Plaque
31
31
No Patient Involvement
28
28
Perforation
24
24
Insufficient Information
19
19
No Code Available
16
16
Swelling/ Edema
12
12
Pancreatitis
10
10
Hemorrhage/Bleeding
9
9
Pain
8
8
Internal Organ Perforation
5
5
Inflammation
5
5
Tingling
4
4
Bacterial Infection
4
4
No Information
4
4
Discomfort
4
4
Foreign body, removal of
3
3
Laceration(s) of Esophagus
3
3
Twitching
3
3
Hemostasis
2
2
Fever
2
2
Perforation of Esophagus
2
2
Blood Loss
2
2
Respiratory Failure
1
1
Hematuria
1
1
Surgical procedure, additional
1
1
Bowel Perforation
1
1
Peritonitis
1
1
Nonresorbable materials, unretrieved in body
1
1
Fistula
1
1
Unspecified Infection
1
1
Biliary Cirrhosis
1
1
Death
1
1
Abdominal Pain
1
1
Abrasion
1
1
Air Embolism
1
1
Dysphasia
1
1
Sepsis
1
1
Septic Shock
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
Feb-04-2020
2
Cook Incorporated
II
Sep-28-2022
3
NEO METRICS, INC.
II
Jun-10-2014
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