TPLC - Total Product Life Cycle

• 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 Code: PGT
• Regulation Number: 884.1710
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
MINERVA SURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
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
Connection Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Pressure Problem	5	5
Appropriate Term/Code Not Available	5	5
Device Displays Incorrect Message	5	5
Electrical /Electronic Property Problem	4	4
Fluid/Blood Leak	3	3
Use of Device Problem	3	3
Failure to Prime	2	2
No Apparent Adverse Event	2	2
Packaging Problem	1	1
Off-Label Use	1	1
Unsealed Device Packaging	1	1
Obstruction of Flow	1	1
Break	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	9	9
Perforation	6	6
No Clinical Signs, Symptoms or Conditions	6	6
No Known Impact Or Consequence To Patient	3	3
Exposure to Body Fluids	3	3
Death	2	2
Sepsis	2	2
Uterine Perforation	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
Abdominal Pain	1	1
Air Embolism	1	1
Injury	1	1
Bronchospasm	1	1
Bowel Perforation	1	1