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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device insufflator, hysteroscopic, fluid, closed-loop recirculation with cutter-coagulator, endoscopic, bipolar
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


Premarket Reviews
ManufacturerDecision
IOGYN, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
MINERVA SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 7 7
2016 19 19
2017 39 39
2018 17 17
2019 13 13
2020 7 7
2021 5 5
2022 1 1
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Inoperable 33 33
Adverse Event Without Identified Device or Use Problem 20 20
Communication or Transmission Problem 12 12
Connection Problem 9 9
Electrical /Electronic Property Problem 7 7
Device Displays Incorrect Message 5 5
Pressure Problem 5 5
Appropriate Term/Code Not Available 5 5
Device Packaging Compromised 4 4
Fluid/Blood Leak 4 4
Unsealed Device Packaging 3 3
Use of Device Problem 3 3
Contamination 2 2
Failure to Prime 2 2
Leak/Splash 2 2
Device-Device Incompatibility 2 2
Component or Accessory Incompatibility 2 2
No Apparent Adverse Event 2 2
Packaging Problem 1 1
Delivered as Unsterile Product 1 1
Off-Label Use 1 1
Material Separation 1 1
Break 1 1
Thermal Decomposition of Device 1 1
Component Incompatible 1 1
Tear, Rip or Hole in Device Packaging 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 73 73
Uterine Perforation 11 11
Perforation 6 6
No Clinical Signs, Symptoms or Conditions 6 6
No Known Impact Or Consequence To Patient 5 5
Exposure to Body Fluids 3 3
Death 2 2
Hemorrhage/Bleeding 2 2
Laceration(s) 2 2
Pain 2 2
Sepsis 2 2
No Patient Involvement 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bowel Perforation 1 1
No Information 1 1
No Code Available 1 1
Vomiting 1 1
Injury 1 1
Bronchospasm 1 1
Abdominal Pain 1 1
Air Embolism 1 1

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