TPLC - Total Product Life Cycle

show TPLC since

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Inoperable	33	33
Adverse Event Without Identified Device or Use Problem	21	21
Communication or Transmission Problem	12	12
Connection Problem	9	9
Electrical /Electronic Property Problem	7	7
Device Displays Incorrect Message	5	5
Appropriate Term/Code Not Available	5	5
Pressure Problem	5	5
Device Packaging Compromised	4	4
Fluid/Blood Leak	4	4
Use of Device Problem	3	3
Unsealed Device Packaging	3	3
Leak/Splash	2	2
Component or Accessory Incompatibility	2	2
Device-Device Incompatibility	2	2
Contamination	2	2
Failure to Prime	2	2
No Apparent Adverse Event	2	2
Obstruction of Flow	1	1
Thermal Decomposition of Device	1	1
Packaging Problem	1	1
Delivered as Unsterile Product	1	1
Component Incompatible	1	1
Off-Label Use	1	1
Break	1	1
Tear, Rip or Hole in Device Packaging	1	1
Material Separation	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
No Clinical Signs, Symptoms or Conditions	6	6
Perforation	6	6
No Known Impact Or Consequence To Patient	5	5
Exposure to Body Fluids	3	3
Hemorrhage/Bleeding	3	3
Death	2	2
Sepsis	2	2
No Patient Involvement	2	2
Insufficient Information	2	2
Pain	2	2
Laceration(s)	2	2
Air Embolism	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Abdominal Pain	1	1
No Code Available	1	1
No Information	1	1
Bowel Perforation	1	1
Injury	1	1
Vomiting	1	1
Bronchospasm	1	1