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 coagulator-cutter, endoscopic, bipolar (and accessories)
Regulation Description Bipolar endoscopic coagulator-cutter and accessories.
Product CodeHIN
Regulation Number 884.4150
Device Class 2

MDR Year MDR Reports MDR Events
2021 10 10
2022 1 1
2023 9 9
2024 29 29
2025 43 43
2026 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Break 54 54
Detachment of Device or Device Component 31 31
Material Fragmentation 15 15
Fracture 12 12
Mechanical Problem 8 8
Arcing 5 5
Failure to Cut 5 5
Material Separation 4 4
Insufficient Device Problem Information 3 3
Excessive Heating 3 3
Flare or Flash 2 2
Explosion 2 2
Failure to Seal 1 1
Use of Device Problem 1 1
Arcing of Electrodes 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Sparking 1 1
Crack 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64 64
Insufficient Information 27 27
Foreign Body In Patient 14 14
Superficial (First Degree) Burn 4 4
Burn(s) 3 3
Uterine Perforation 2 2
Convulsion/Seizure 2 2
Swelling/ Edema 1 1
No Consequences Or Impact To Patient 1 1
Unspecified Infection 1 1
Abnormal Blood Gases 1 1

-
-