Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
snare, flexible
Product Code
FDI
Regulation Number
876.4300
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEIJING ZKSK TECHNOLOGY CO.,LTD
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORP.
SUBSTANTIALLY EQUIVALENT
2
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
3
CONMED ENDOSCOPIC TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
ENDOCHOICE, INC.
SUBSTANTIALLY EQUIVALENT
2
FINEMEDIX CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HANGZHOU AGS MEDTECH CO., LTD
SUBSTANTIALLY EQUIVALENT
1
HANGZHOU AGS MEDTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
INCORE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
INTELLIGENT ENDOSCOPY
SUBSTANTIALLY EQUIVALENT
1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
MEDI-GLOBE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MICRO- TECH (NANJING) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS MEDICAL SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
1
OVESCO ENDOSCOPY AG
SUBSTANTIALLY EQUIVALENT
1
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
1
UNITED STATES ENDOSCOPY
SUBSTANTIALLY EQUIVALENT
1
1. K103611
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
2. K122462
ROTH NET RETRIEVER
3. K133513
MULTI-STAGE SNARE
4. K151197
Lariat snare
5. K182909
Roth Net Retriever Product Line
6. K200745
Lariat, Hot/Cold Snare
UNITED STATES ENDOSCOPY GROUP, INC.
SUBSTANTIALLY EQUIVALENT
6
1. K103611
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
2. K122462
ROTH NET RETRIEVER
3. K133513
MULTI-STAGE SNARE
4. K151197
Lariat snare
5. K182909
Roth Net Retriever Product Line
6. K200745
Lariat, Hot/Cold Snare
WILSON-COOK MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
WILSON-COOK MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
345
345
2015
194
194
2016
223
223
2017
154
154
2018
181
181
2019
135
135
2020
487
487
2021
211
211
2022
246
246
2023
209
209
2024
77
77
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Cut
811
811
Break
379
379
Detachment Of Device Component
367
367
Failure to Deliver Energy
280
280
Entrapment of Device
163
163
Unsealed Device Packaging
144
144
Adverse Event Without Identified Device or Use Problem
126
126
Detachment of Device or Device Component
105
105
Retraction Problem
80
80
Electrical /Electronic Property Problem
66
66
Device Contamination with Chemical or Other Material
65
65
Difficult to Open or Close
60
60
Positioning Problem
59
59
Material Deformation
50
50
Device Operates Differently Than Expected
46
46
Defective Device
43
43
Material Twisted/Bent
41
41
Device-Device Incompatibility
38
38
Mechanical Problem
35
35
Use of Device Problem
19
19
Material Split, Cut or Torn
17
17
Failure to Conduct
15
15
Device Dislodged or Dislocated
13
13
Human-Device Interface Problem
13
13
Appropriate Term/Code Not Available
11
11
Difficult to Advance
9
9
Failure to Fold
9
9
Material Separation
9
9
Difficult to Remove
8
8
Failure to Advance
7
7
Off-Label Use
7
7
Therapeutic or Diagnostic Output Failure
6
6
Physical Resistance/Sticking
5
5
Positioning Failure
5
5
Bent
5
5
Sparking
5
5
Failure to Align
5
5
Activation, Positioning or Separation Problem
5
5
Device Markings/Labelling Problem
4
4
Device Contaminated During Manufacture or Shipping
4
4
Overheating of Device
4
4
Inappropriate/Inadequate Shock/Stimulation
3
3
Component Falling
3
3
Material Integrity Problem
3
3
Sticking
3
3
Improper or Incorrect Procedure or Method
3
3
Unintended Movement
3
3
Insufficient Information
3
3
Scratched Material
2
2
Suction Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Failure to Fire
2
2
Communication or Transmission Problem
2
2
Connection Problem
2
2
Material Protrusion/Extrusion
2
2
Mechanical Jam
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Physical Resistance
2
2
Fracture
2
2
Device Slipped
2
2
Device Difficult to Setup or Prepare
2
2
Loss of Power
1
1
Premature Activation
1
1
Failure To Service
1
1
Device Alarm System
1
1
Fluid/Blood Leak
1
1
Melted
1
1
Nonstandard Device
1
1
Device Emits Odor
1
1
Energy Output Problem
1
1
Material Fragmentation
1
1
Insufficient Heating
1
1
Material Discolored
1
1
Energy Output To Patient Tissue Incorrect
1
1
Crack
1
1
Degraded
1
1
Loss of or Failure to Bond
1
1
Component(s), broken
1
1
Mechanics Altered
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Impedance Problem
1
1
Separation Failure
1
1
Folded
1
1
Deformation Due to Compressive Stress
1
1
Obstruction of Flow
1
1
Structural Problem
1
1
Device Inoperable
1
1
Unraveled Material
1
1
Device Handling Problem
1
1
Activation Problem
1
1
Wrong Label
1
1
Torn Material
1
1
Protective Measures Problem
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1239
1239
No Clinical Signs, Symptoms or Conditions
623
623
No Known Impact Or Consequence To Patient
216
216
No Patient Involvement
140
140
Hemorrhage/Bleeding
106
106
Perforation
46
46
No Code Available
27
27
Tissue Damage
25
25
Insufficient Information
16
16
Unspecified Tissue Injury
11
11
Bowel Perforation
11
11
Burn(s)
11
11
Hematoma
9
9
Device Embedded In Tissue or Plaque
8
8
No Information
8
8
Abdominal Pain
7
7
Foreign Body In Patient
7
7
Pancreatitis
4
4
Fever
4
4
Pain
4
4
Electric Shock
4
4
Peritonitis
2
2
Stenosis
2
2
Blood Loss
2
2
Laceration(s)
2
2
Internal Organ Perforation
2
2
Gastrointestinal Hemorrhage
2
2
Melena
1
1
Unspecified Hepatic or Biliary Problem
1
1
Swelling/ Edema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Failure to Anastomose
1
1
Pneumonia
1
1
Renal Failure
1
1
Shock
1
1
Abrasion
1
1
Bacterial Infection
1
1
Bowel Burn
1
1
Chest Pain
1
1
Death
1
1
Diarrhea
1
1
Tissue Breakdown
1
1
Cancer
1
1
Unspecified Heart Problem
1
1
Discomfort
1
1
Injury
1
1
Foreign body, removal of
1
1
Burn, Thermal
1
1
Surgical procedure, additional
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Mar-04-2021
2
Boston Scientific Corporation
II
Aug-05-2020
3
Boston Scientific Corporation
II
Jun-21-2012
4
Olympus America Inc.
II
Aug-18-2010
5
US Endoscopy Group Inc
II
Oct-01-2015
-
-