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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
85
85
Device Problems
MDRs with this Device Problem
Events in those MDRs
Peeled/Delaminated
442
442
Detachment Of Device Component
378
378
Material Separation
124
124
Break
108
108
Adverse Event Without Identified Device or Use Problem
64
64
Detachment of Device or Device Component
31
31
Fracture
28
28
Positioning Problem
23
23
Material Fragmentation
22
22
Migration or Expulsion of Device
20
20
Material Twisted/Bent
19
19
Unraveled Material
19
19
Material Deformation
18
18
Difficult to Advance
12
12
Improper or Incorrect Procedure or Method
11
11
Entrapment of Device
11
11
Deformation Due to Compressive Stress
10
10
Device Damaged by Another Device
10
10
Flaked
9
9
Appropriate Term/Code Not Available
9
9
Insufficient Information
9
9
Off-Label Use
8
8
Device Damaged Prior to Use
8
8
Difficult to Remove
8
8
Positioning Failure
7
7
Material Frayed
7
7
Material Integrity Problem
6
6
Device Contaminated During Manufacture or Shipping
6
6
Use of Device Problem
6
6
Defective Device
5
5
Unsealed Device Packaging
5
5
Physical Resistance/Sticking
5
5
Material Too Rigid or Stiff
5
5
Bent
5
5
Device-Device Incompatibility
4
4
Device Dislodged or Dislocated
4
4
Device Operates Differently Than Expected
4
4
Device Contamination with Chemical or Other Material
4
4
Material Disintegration
4
4
Difficult to Insert
4
4
Microbial Contamination of Device
4
4
Accessory Incompatible
3
3
Material Protrusion/Extrusion
3
3
Material Split, Cut or Torn
3
3
Contamination /Decontamination Problem
3
3
Particulates
2
2
Inadequate Lubrication
2
2
No Apparent Adverse Event
2
2
Migration
2
2
Failure to Advance
2
2
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
341
341
No Known Impact Or Consequence To Patient
100
100
Foreign Body In Patient
77
77
Device Embedded In Tissue or Plaque
31
31
No Patient Involvement
28
28
Perforation
24
24
Insufficient Information
23
23
No Code Available
16
16
Swelling/ Edema
12
12
Hemorrhage/Bleeding
11
11
Pancreatitis
11
11
Pain
8
8
Internal Organ Perforation
6
6
Inflammation
5
5
No Information
4
4
Laceration(s) of Esophagus
4
4
Tingling
4
4
Discomfort
4
4
Bacterial Infection
4
4
Foreign body, removal of
3
3
Twitching
3
3
Gastrointestinal Hemorrhage
2
2
Sepsis
2
2
Perforation of Esophagus
2
2
Blood Loss
2
2
Fever
2
2
Hemostasis
2
2
Laceration(s)
2
2
Hematuria
1
1
Bowel Perforation
1
1
Abrasion
1
1
Death
1
1
Peritonitis
1
1
Retroperitoneal Hemorrhage
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Septic Shock
1
1
Vomiting
1
1
Nonresorbable materials, unretrieved in body
1
1
Surgical procedure, additional
1
1
Biliary Cirrhosis
1
1
Dysphasia
1
1
Unspecified Infection
1
1
Air Embolism
1
1
Respiratory Failure
1
1
Fistula
1
1
Abdominal Pain
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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