• 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
Regulation Description Manual gastroenterology-urology surgical instrument and accessories.
Product CodeFHQ
Regulation Number 876.4730
Device Class 1

MDR Year MDR Reports MDR Events
2020 50 50
2021 57 57
2022 64 64
2023 63 63
2024 71 71
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 122 122
Retraction Problem 91 91
Use of Device Problem 71 71
Misfire 40 40
Adverse Event Without Identified Device or Use Problem 23 23
Break 21 21
Mechanical Problem 20 20
Device-Device Incompatibility 14 14
Difficult to Open or Close 10 10
Failure to Align 5 5
Contamination 3 3
Defective Device 3 3
Therapeutic or Diagnostic Output Failure 3 3
Material Twisted/Bent 2 2
Appropriate Term/Code Not Available 2 2
Material Separation 2 2
Material Frayed 1 1
Device Fell 1 1
Suction Problem 1 1
Material Fragmentation 1 1
Positioning Problem 1 1
Defective Component 1 1
Packaging Problem 1 1
Fracture 1 1
Premature Separation 1 1
Material Deformation 1 1
Difficult to Advance 1 1
Unsealed Device Packaging 1 1
Activation Failure 1 1
Tear, Rip or Hole in Device Packaging 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure of Device to Self-Test 1 1
Entrapment of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 203 203
Foreign Body In Patient 37 37
No Consequences Or Impact To Patient 23 23
No Known Impact Or Consequence To Patient 17 17
Device Embedded In Tissue or Plaque 14 14
Insufficient Information 13 13
Hemorrhage/Bleeding 4 4
Pain 2 2
Hematoma 2 2
Abscess 1 1
Constipation 1 1
No Patient Involvement 1 1
Erosion 1 1
Dyspareunia 1 1
Unspecified Tissue Injury 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boss Instruments, Ltd. II Aug-05-2020
2 Dufner Instrumente GmbH II Jul-10-2020
-
-