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TPLC
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Device
biopsy needle
Product Code
FCG
Regulation Number
876.1075
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIBBINSTRUMENTS AB
SUBSTANTIALLY EQUIVALENT
1
1. K212423
EndoDrill® Model X
COOK IRELAND LTD.
SUBSTANTIALLY EQUIVALENT
2
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
2019
229
229
2020
240
240
2021
289
289
2022
304
304
2023
430
430
2024
67
67
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
371
371
Fracture
270
270
Material Twisted/Bent
203
203
Adverse Event Without Identified Device or Use Problem
155
155
Improper or Incorrect Procedure or Method
128
128
Off-Label Use
114
114
Retraction Problem
85
85
Physical Resistance/Sticking
84
84
Detachment of Device or Device Component
66
66
Difficult to Remove
41
41
Material Perforation
36
36
Material Separation
33
33
Use of Device Problem
32
32
Mechanical Problem
27
27
Difficult to Advance
24
24
Device Contamination with Chemical or Other Material
21
21
Device Damaged Prior to Use
20
20
Insufficient Information
20
20
Material Deformation
15
15
Device-Device Incompatibility
14
14
Failure to Advance
14
14
Device Fell
12
12
Material Puncture/Hole
11
11
Difficult to Insert
10
10
Material Fragmentation
10
10
Dent in Material
10
10
No Apparent Adverse Event
10
10
Failure to Obtain Sample
9
9
Structural Problem
8
8
Material Split, Cut or Torn
8
8
Positioning Problem
8
8
Output Problem
8
8
Device Markings/Labelling Problem
7
7
Defective Device
7
7
Activation, Positioning or Separation Problem
7
7
Failure to Eject
6
6
Separation Problem
5
5
Difficult to Open or Close
5
5
Tear, Rip or Hole in Device Packaging
5
5
Defective Component
5
5
Component Missing
5
5
Device Slipped
5
5
Loss of or Failure to Bond
5
5
Leak/Splash
5
5
Loose or Intermittent Connection
5
5
Unsealed Device Packaging
4
4
Contamination
4
4
No Display/Image
4
4
Entrapment of Device
4
4
Misfire
4
4
Device Contaminated During Manufacture or Shipping
4
4
Material Integrity Problem
3
3
Material Protrusion/Extrusion
3
3
Device Damaged by Another Device
3
3
Dull, Blunt
3
3
Material Frayed
3
3
Positioning Failure
3
3
Peeled/Delaminated
3
3
Shipping Damage or Problem
3
3
Appropriate Term/Code Not Available
3
3
Mechanical Jam
2
2
Activation Problem
2
2
Migration
2
2
Material Too Rigid or Stiff
2
2
Nonstandard Device
2
2
Premature Activation
2
2
Display or Visual Feedback Problem
2
2
Expiration Date Error
2
2
Unraveled Material
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Device Dislodged or Dislocated
1
1
Separation Failure
1
1
Difficult or Delayed Activation
1
1
Failure to Fire
1
1
Malposition of Device
1
1
Deformation Due to Compressive Stress
1
1
Contamination /Decontamination Problem
1
1
Failure to Deliver
1
1
Fitting Problem
1
1
Unintended Ejection
1
1
Fluid/Blood Leak
1
1
Difficult to Fold, Unfold or Collapse
1
1
Disconnection
1
1
Accessory Incompatible
1
1
Crack
1
1
Degraded
1
1
Failure to Prime
1
1
Incorrect Measurement
1
1
Self-Activation or Keying
1
1
Inadequacy of Device Shape and/or Size
1
1
Difficult or Delayed Separation
1
1
Unclear Information
1
1
Mechanics Altered
1
1
Packaging Problem
1
1
Activation Failure
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
786
786
No Consequences Or Impact To Patient
243
243
Foreign Body In Patient
201
201
No Known Impact Or Consequence To Patient
134
134
Hemorrhage/Bleeding
60
60
Insufficient Information
39
39
Gastrointestinal Hemorrhage
26
26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Device Embedded In Tissue or Plaque
20
20
Pancreatitis
18
18
No Patient Involvement
18
18
Pneumothorax
17
17
Abdominal Pain
16
16
Pain
15
15
Fever
14
14
Unspecified Infection
13
13
Hematoma
12
12
Peritonitis
12
12
No Code Available
12
12
Needle Stick/Puncture
10
10
Abscess
10
10
Inflammation
9
9
Injury
8
8
Perforation
8
8
Pneumonia
7
7
Blood Loss
7
7
Hypoxia
6
6
Unspecified Tissue Injury
6
6
Unspecified Hepatic or Biliary Problem
6
6
Low Blood Pressure/ Hypotension
5
5
Hemoptysis
5
5
Sepsis
5
5
Respiratory Failure
4
4
Radiation Exposure, Unintended
4
4
Thrombocytopenia
4
4
Cough
4
4
Death
4
4
Biliary Cirrhosis
3
3
Cardiac Arrest
3
3
Dyspnea
3
3
Fibrosis
3
3
Septic Shock
3
3
Vomiting
3
3
Unspecified Gastrointestinal Problem
3
3
Discomfort
2
2
No Information
2
2
Wheezing
2
2
Bronchospasm
2
2
Respiratory Tract Infection
2
2
Obstruction/Occlusion
2
2
Perforation of Vessels
2
2
Confusion/ Disorientation
2
2
Hemothorax
2
2
Nausea
2
2
Exposure to Body Fluids
2
2
Bradycardia
2
2
Air Embolism
2
2
Cyst(s)
2
2
Vessel Or Plaque, Device Embedded In
1
1
Dysphagia/ Odynophagia
1
1
Fistula
1
1
Granuloma
1
1
Headache
1
1
Abrasion
1
1
Chest Pain
1
1
Internal Organ Perforation
1
1
Liver Damage/Dysfunction
1
1
Muscle Weakness
1
1
Hepatitis
1
1
Hemostasis
1
1
Pulmonary Emphysema
1
1
Extravasation
1
1
Pseudoaneurysm
1
1
Unspecified Respiratory Problem
1
1
Pleural Empyema
1
1
Syncope/Fainting
1
1
Sedation
1
1
Sore Throat
1
1
Decreased Respiratory Rate
1
1
Sleep Dysfunction
1
1
Dizziness
1
1
Strangulation
1
1
Respiratory Distress
1
1
Muscle Hypotonia
1
1
Cancer Cells Dissemination
1
1
Localized Skin Lesion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aomori Olympus Co., Ltd.
II
Feb-05-2021
2
Covidien Llc
II
Aug-05-2020
3
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
4
Olympus Corporation of the Americas
III
May-19-2023
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