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TPLC
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show TPLC since
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Device
ligator, hemorrhoidal
Product Code
FHN
Regulation Number
876.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
AGENCY FOR MEDICAL INNOVATIONS GMBH
SUBSTANTIALLY EQUIVALENT
1
1. K150718
Wi-3 HAL-RAR System
BEIJING ZKSK TECHNOLOGY CO.,LTD
SUBSTANTIALLY EQUIVALENT
1
HAEMOBAND SURGICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
INX MEDICAL
SUBSTANTIALLY EQUIVALENT
1
LEO MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
THD SPA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
208
208
2015
228
228
2016
202
202
2017
303
303
2018
318
318
2019
372
372
2020
70
70
2021
16
16
2022
60
60
2023
47
47
Device Problems
MDRs with this Device Problem
Events in those MDRs
Positioning Failure
667
667
Failure to Fire
367
367
Premature Activation
346
346
Break
265
265
Appropriate Term/Code Not Available
257
257
Detachment of Device or Device Component
69
69
Separation Failure
60
60
Difficult to Remove
54
54
Failure To Adhere Or Bond
43
43
Difficult or Delayed Positioning
35
35
Misfire
35
35
Adverse Event Without Identified Device or Use Problem
28
28
Defective Device
27
27
Use of Device Problem
21
21
Human-Device Interface Problem
16
16
Activation, Positioning or Separation Problem
16
16
Mechanical Problem
14
14
Detachment Of Device Component
10
10
Failure to Disconnect
10
10
Entrapment of Device
9
9
Defective Component
8
8
Mechanical Jam
7
7
Physical Resistance/Sticking
6
6
Material Separation
5
5
Device Difficult to Setup or Prepare
5
5
Migration or Expulsion of Device
4
4
Failure to Advance
4
4
Material Twisted/Bent
4
4
Separation Problem
4
4
Device Operates Differently Than Expected
4
4
Material Integrity Problem
3
3
Failure to Unfold or Unwrap
3
3
Loss of or Failure to Bond
3
3
Component Falling
2
2
Bent
2
2
Retraction Problem
2
2
Material Deformation
2
2
Device Dislodged or Dislocated
2
2
Difficult or Delayed Separation
2
2
Lack of Effect
1
1
Device Fell
1
1
Activation Problem
1
1
Patient Device Interaction Problem
1
1
Material Split, Cut or Torn
1
1
Ejection Problem
1
1
Failure to Eject
1
1
Device Contamination with Chemical or Other Material
1
1
Device Disinfection Or Sterilization Issue
1
1
Device Markings/Labelling Problem
1
1
Device-Device Incompatibility
1
1
Difficult to Advance
1
1
Difficult to Open or Close
1
1
Difficult to Open or Remove Packaging Material
1
1
Material Protrusion/Extrusion
1
1
Unintended Movement
1
1
Misassembly by Users
1
1
Insufficient Information
1
1
Unintended System Motion
1
1
Fracture
1
1
Device Reprocessing Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Component Missing
1
1
Component or Accessory Incompatibility
1
1
Difficult or Delayed Activation
1
1
Failure to Form Staple
1
1
Failure to Cut
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1506
1506
No Known Impact Or Consequence To Patient
145
145
No Clinical Signs, Symptoms or Conditions
89
89
Foreign Body In Patient
54
54
Hemorrhage/Bleeding
34
34
Tissue Damage
23
23
No Patient Involvement
11
11
No Code Available
10
10
Blood Loss
6
6
Death
6
6
No Information
5
5
Hemostasis
4
4
Laceration(s)
4
4
Gastrointestinal Hemorrhage
3
3
Unspecified Tissue Injury
3
3
Device Embedded In Tissue or Plaque
2
2
Fever
2
2
Hemoptysis
1
1
Peritonitis
1
1
Laceration(s) of Esophagus
1
1
Skin Tears
1
1
Pain
1
1
Perforation
1
1
Septic Shock
1
1
Erythema
1
1
Abdominal Pain
1
1
Abscess
1
1
Bowel Perforation
1
1
Melena
1
1
Insufficient Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Aug-22-2011
2
Boston Scientific Corporation
II
Sep-02-2009
3
Cook Endoscopy
II
Oct-19-2010
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