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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
MDR Year
MDR Reports
MDR Events
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
280
280
Material Separation
70
70
Break
66
66
Adverse Event Without Identified Device or Use Problem
50
50
Detachment of Device or Device Component
27
27
Positioning Problem
20
20
Material Twisted/Bent
18
18
Fracture
16
16
Material Fragmentation
15
15
Material Deformation
11
11
Deformation Due to Compressive Stress
10
10
Unraveled Material
9
9
Difficult to Advance
9
9
Entrapment of Device
9
9
Appropriate Term/Code Not Available
9
9
Insufficient Information
7
7
Positioning Failure
7
7
Off-Label Use
5
5
Difficult to Remove
5
5
Defective Device
5
5
Use of Device Problem
5
5
Improper or Incorrect Procedure or Method
5
5
Physical Resistance/Sticking
5
5
Microbial Contamination of Device
4
4
Device Damaged by Another Device
4
4
Material Too Rigid or Stiff
4
4
Unsealed Device Packaging
4
4
Difficult to Insert
3
3
Flaked
3
3
Contamination /Decontamination Problem
3
3
Device Damaged Prior to Use
2
2
Device Contaminated During Manufacture or Shipping
2
2
Material Integrity Problem
2
2
Accessory Incompatible
2
2
Particulates
2
2
Material Split, Cut or Torn
2
2
Mechanical Jam
2
2
Migration
1
1
Scratched Material
1
1
No Apparent Adverse Event
1
1
Inadequate Lubrication
1
1
Loose or Intermittent Connection
1
1
Product Quality Problem
1
1
Crack
1
1
Material Frayed
1
1
Material Protrusion/Extrusion
1
1
Device-Device Incompatibility
1
1
Device Dislodged or Dislocated
1
1
Tear, Rip or Hole in Device Packaging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
287
287
No Consequences Or Impact To Patient
158
158
Foreign Body In Patient
47
47
No Known Impact Or Consequence To Patient
23
23
Insufficient Information
19
19
No Patient Involvement
13
13
Swelling/ Edema
12
12
Perforation
11
11
Pancreatitis
10
10
No Code Available
8
8
Device Embedded In Tissue or Plaque
8
8
Hemorrhage/Bleeding
8
8
Pain
7
7
Internal Organ Perforation
4
4
Tingling
4
4
Bacterial Infection
4
4
Discomfort
4
4
Laceration(s) of Esophagus
3
3
No Information
3
3
Twitching
3
3
Inflammation
2
2
Perforation of Esophagus
2
2
Respiratory Failure
1
1
Bowel Perforation
1
1
Peritonitis
1
1
Laceration(s)
1
1
Sepsis
1
1
Septic Shock
1
1
Biliary Cirrhosis
1
1
Death
1
1
Fever
1
1
Fistula
1
1
Unspecified Infection
1
1
Abdominal Pain
1
1
Abrasion
1
1
Air Embolism
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cook Inc.
II
Feb-04-2020
2
Cook Incorporated
II
Sep-28-2022
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