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 holder, needle, gastroenterologic
Product CodeFHQ
Regulation Number 876.4730
Device Class 1

MDR Year MDR Reports MDR Events
2014 37 37
2015 67 67
2016 74 74
2017 101 101
2018 104 104
2019 80 80
2020 50 50
2021 57 57
2022 64 64
2023 63 63
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 200 200
Detachment Of Device Component 181 181
Retraction Problem 179 179
Break 83 83
Use of Device Problem 60 60
Misfire 41 41
Adverse Event Without Identified Device or Use Problem 31 31
Mechanical Problem 23 23
Device-Device Incompatibility 16 16
Difficult to Open or Close 9 9
Device Operates Differently Than Expected 8 8
Failure to Align 6 6
Material Twisted/Bent 5 5
Tear, Rip or Hole in Device Packaging 4 4
Component Missing 4 4
Material Separation 3 3
Entrapment of Device 3 3
Fracture 3 3
Contamination 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Or Device Fragments Location Unknown 3 3
Device Contaminated During Manufacture or Shipping 3 3
Device Contamination with Chemical or Other Material 2 2
Appropriate Term/Code Not Available 2 2
Positioning Failure 2 2
Failure To Adhere Or Bond 2 2
Difficult to Insert 2 2
Defective Component 2 2
Improper or Incorrect Procedure or Method 2 2
Other (for use when an appropriate device code cannot be identified) 2 2
Defective Device 2 2
Device Packaging Compromised 2 2
Difficult to Advance 1 1
Unknown (for use when the device problem is not known) 1 1
Solder Joint Fracture 1 1
Bent 1 1
Failure to Capture 1 1
Component Falling 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Device Slipped 1 1
Unsealed Device Packaging 1 1
Difficult to Remove 1 1
Device Handling Problem 1 1
Activation Failure 1 1
Firing Problem 1 1
Device Fell 1 1
Failure of Device to Self-Test 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Packaging Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 223 223
No Clinical Signs, Symptoms or Conditions 167 167
Device Embedded In Tissue or Plaque 132 132
No Known Impact Or Consequence To Patient 120 120
Foreign Body In Patient 44 44
Pain 14 14
Insufficient Information 11 11
No Information 8 8
No Code Available 6 6
No Patient Involvement 6 6
Urinary Retention 4 4
Hemorrhage/Bleeding 4 4
Hematoma 3 3
Vessel Or Plaque, Device Embedded In 2 2
Abscess 1 1
Erosion 1 1
Unspecified Infection 1 1
Nerve Damage 1 1
Tissue Damage 1 1
Constipation 1 1
Dyspareunia 1 1
Unknown (for use when the patient's condition is not known) 1 1
Nonresorbable materials, unretrieved in body 1 1
Discomfort 1 1
Obstruction/Occlusion 1 1
Surgical procedure, additional 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boss Instruments, Ltd. II Aug-05-2020
2 Cook Inc. II Jun-08-2017
3 Davol, Inc., Sub. C. R. Bard, Inc. II Sep-06-2009
4 Dufner Instrumente GmbH II Jul-10-2020
-
-