TPLC - Total Product Life Cycle

• Device: insufflator, hysteroscopic
• Product Code: HIG
• Regulation Number: 884.1700
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
KARL STORZ SE & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
THERMEDX, LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	66	66
2020	31	31
2021	130	130
2022	66	66
2023	33	33
2024	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Fragmentation	132	132
Leak/Splash	36	36
Adverse Event Without Identified Device or Use Problem	17	17
Incorrect Measurement	16	16
Insufficient Information	13	13
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Detachment of Device or Device Component	11	11
Defective Device	7	7
Output Problem	7	7
Use of Device Problem	7	7
Break	7	7
Infusion or Flow Problem	6	6
Pressure Problem	6	6
Display or Visual Feedback Problem	5	5
Fluid/Blood Leak	4	4
Nonstandard Device	4	4
Suction Problem	4	4
Defective Component	4	4
Material Rupture	4	4
Material Separation	4	4
Improper Flow or Infusion	4	4
Application Program Problem	4	4
Mechanical Problem	3	3
Pumping Stopped	2	2
Shipping Damage or Problem	2	2
Insufficient Flow or Under Infusion	2	2
Volume Accuracy Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Loose or Intermittent Connection	2	2
Fracture	2	2
Burst Container or Vessel	2	2
Device Displays Incorrect Message	2	2
Packaging Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Suction Failure	2	2
Crack	2	2
Separation Problem	1	1
Lack of Effect	1	1
No Apparent Adverse Event	1	1
Protective Measures Problem	1	1
Material Split, Cut or Torn	1	1
Physical Resistance/Sticking	1	1
Incomplete or Inadequate Connection	1	1
Power Problem	1	1
Optical Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Material Twisted/Bent	1	1
Mechanics Altered	1	1
Inadequate User Interface	1	1
Calibration Problem	1	1
Communication or Transmission Problem	1	1
Connection Problem	1	1
Contamination	1	1
No Audible Alarm	1	1
Alarm Not Visible	1	1
False Negative Result	1	1
Excess Flow or Over-Infusion	1	1
Inability to Irrigate	1	1
Delivered as Unsterile Product	1	1
No Device Output	1	1
Increase in Pressure	1	1
Failure to Prime	1	1
Off-Label Use	1	1
Tear, Rip or Hole in Device Packaging	1	1
Obstruction of Flow	1	1
Failure to Calibrate	1	1
Low Readings	1	1
Failure to Align	1	1
Failure to Cut	1	1
Self-Activation or Keying	1	1
Material Puncture/Hole	1	1
Product Quality Problem	1	1
Misconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	200	200
No Known Impact Or Consequence To Patient	36	36
No Consequences Or Impact To Patient	35	35
Insufficient Information	20	20
Hypervolemia	8	8
No Patient Involvement	7	7
No Information	5	5
Unspecified Heart Problem	4	4
Pulmonary Edema	4	4
Perforation	3	3
No Code Available	3	3
Loss of consciousness	2	2
Hyponatremia	2	2
Unspecified Tissue Injury	2	2
Pulmonary Embolism	2	2
Air Embolism	2	2
Airway Obstruction	1	1
Atrial Fibrillation	1	1
Exposure to Body Fluids	1	1
Bradycardia	1	1
Cardiac Arrest	1	1
Cardiopulmonary Arrest	1	1
Cyanosis	1	1
Death	1	1
Fever	1	1
Low Blood Pressure/ Hypotension	1	1
Laceration(s)	1	1
Internal Organ Perforation	1	1
Peritoneal Laceration(s)	1	1
Septic Shock	1	1
Uterine Perforation	1	1
Heart Failure	1	1
Incomplete Induced Abortion	1	1
Brain Injury	1	1
Distress	1	1
Unspecified Kidney or Urinary Problem	1	1
Bowel Perforation	1	1
Foreign Body In Patient	1	1
Pallor	1	1
Low Oxygen Saturation	1	1
Ischemic Heart Disease	1	1
Blood Loss	1	1
Bronchospasm	1	1
Embolism/Embolus	1	1
Thrombosis/Thrombus	1	1
Unspecified Vascular Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	WOM World Of Medicine AG	II	Jan-05-2024
2	WOM World of Medicine AG	II	Sep-24-2021
3	WOM World of Medicine AG	II	Sep-30-2019