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TPLC
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Device
biopsy needle
Regulation Description
Gastroenterology-urology biopsy instrument.
Product Code
FCG
Regulation Number
876.1075
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIBBINSTRUMENTS AB
SUBSTANTIALLY EQUIVALENT
1
COOK IRELAND LTD.
SUBSTANTIALLY EQUIVALENT
3
FINEMEDIX CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
LIMACA MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
1
SUZHOU LEAPMED HEALTHCARE CORPORATION
SUBSTANTIALLY EQUIVALENT
2
USHARE MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
240
240
2021
289
289
2022
304
304
2023
431
431
2024
446
446
2025
264
264
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
485
485
Fracture
297
297
Material Twisted/Bent
262
262
Improper or Incorrect Procedure or Method
185
185
Adverse Event Without Identified Device or Use Problem
181
181
Off-Label Use
154
154
Detachment of Device or Device Component
114
114
Retraction Problem
105
105
Physical Resistance/Sticking
95
95
Material Separation
48
48
Use of Device Problem
44
44
Difficult to Remove
44
44
Material Perforation
42
42
Mechanical Problem
36
36
Material Split, Cut or Torn
27
27
Device Damaged Prior to Use
25
25
Difficult to Advance
25
25
Device Contamination with Chemical or Other Material
24
24
Dent in Material
21
21
Insufficient Information
21
21
Failure to Obtain Sample
20
20
Device-Device Incompatibility
18
18
Difficult to Open or Close
17
17
Material Fragmentation
16
16
Failure to Advance
16
16
Material Puncture/Hole
16
16
Difficult to Insert
13
13
Material Deformation
11
11
Structural Problem
11
11
Device Markings/Labelling Problem
10
10
No Apparent Adverse Event
10
10
Device Fell
9
9
Loss of or Failure to Bond
9
9
Mechanical Jam
8
8
Positioning Problem
7
7
Defective Device
7
7
Contamination
7
7
Output Problem
6
6
Unintended Movement
6
6
Failure to Eject
6
6
Material Integrity Problem
5
5
Material Protrusion/Extrusion
5
5
Leak/Splash
5
5
Dull, Blunt
5
5
Tear, Rip or Hole in Device Packaging
5
5
Component Missing
5
5
Separation Problem
5
5
Unstable
5
5
Device Slipped
5
5
Positioning Failure
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1343
1343
Foreign Body In Patient
211
211
No Consequences Or Impact To Patient
125
125
Hemorrhage/Bleeding
89
89
No Known Impact Or Consequence To Patient
76
76
Insufficient Information
54
54
Pancreatitis
38
38
Gastrointestinal Hemorrhage
31
31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
24
24
Abdominal Pain
21
21
Fever
20
20
Peritonitis
18
18
Pneumothorax
18
18
Pain
16
16
Device Embedded In Tissue or Plaque
15
15
Unspecified Infection
15
15
No Patient Involvement
14
14
Hematoma
12
12
Perforation
11
11
Unspecified Hepatic or Biliary Problem
9
9
Inflammation
9
9
No Code Available
8
8
Low Blood Pressure/ Hypotension
8
8
Abscess
7
7
Needle Stick/Puncture
7
7
Unspecified Tissue Injury
6
6
Pneumonia
6
6
Hypoxia
6
6
Air Embolism
5
5
Injury
5
5
Sepsis
5
5
Respiratory Failure
5
5
Cough
4
4
Thrombocytopenia
4
4
Low Oxygen Saturation
4
4
Blood Loss
4
4
Hemoptysis
4
4
Biliary Cirrhosis
4
4
Fibrosis
3
3
Obstruction/Occlusion
3
3
Dyspnea
3
3
Septic Shock
3
3
Death
3
3
Vomiting
3
3
Cardiac Arrest
3
3
Unspecified Gastrointestinal Problem
3
3
Confusion/ Disorientation
2
2
Laceration(s)
2
2
Nausea
2
2
Respiratory Tract Infection
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Aomori Olympus Co., Ltd.
II
Feb-05-2021
2
Bard Peripheral Vascular Inc
II
Sep-20-2024
3
Cook Medical Incorporated
II
May-16-2024
4
Covidien Llc
II
Aug-05-2020
5
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-06-2024
6
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
7
Olympus Corporation of the Americas
III
May-19-2023
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