Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
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 Back to Search Results
Device ligator, hemorrhoidal
Product CodeFHN
Regulation Number 876.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
AGENCY FOR MEDICAL INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
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
-
-