• 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 insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar
Regulation Description Closed loop hysteroscopic insufflator with cutter-coagulator.
Definition to distend the uterus with saline and maintain distension through closed-loop recirculation of filtered distension fluid during diagnostic and operative hysteroscopy. It is also intended for cutting and coagulation of uterine tissue.
Product CodePGT
Regulation Number 884.1710
Device Class 2

MDR Year MDR Reports MDR Events
2016 19 19
2017 39 39
2018 17 17
2019 13 13
2020 7 7
2021 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Inoperable 32 32
Adverse Event Without Identified Device or Use Problem 18 18
Communication or Transmission Problem 11 11
Electrical /Electronic Property Problem 7 7
Connection Problem 5 5
Device Displays Incorrect Message 5 5
Pressure Problem 5 5
Appropriate Term/Code Not Available 5 5
Device Packaging Compromised 4 4
Fluid Leak 4 4
Unsealed Device Packaging 3 3
Failure to Prime 2 2
Leak/Splash 2 2
Device-Device Incompatibility 2 2
Component or Accessory Incompatibility 2 2
Contamination 2 2
Obstruction of Flow 1 1
Delivered as Unsterile Product 1 1
Material Separation 1 1
Thermal Decomposition of Device 1 1
Component Incompatible 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 69 69
Uterine Perforation 8 8
Perforation 6 6
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 2 2
No Patient Involvement 2 2
Sepsis 2 2
Death 2 2
Hemorrhage/Bleeding 2 2
Laceration(s) 2 2
Pain 2 2
Vomiting 1 1
Air Embolism 1 1
Injury 1 1
Bronchospasm 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
No Information 1 1
No Code Available 1 1

-
-