TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
CORE ACCESS SURGICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
FREYJA HEALTHCARE, LLC
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ SE & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PALLIARE , LTD.
	SUBSTANTIALLY EQUIVALENT	2
PREMIUM MEDICAL TECHNOLOGY, LLC
	SUBSTANTIALLY EQUIVALENT	1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SMARTSURGN, INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAUTONA GROUP
	SUBSTANTIALLY EQUIVALENT	1
TAUTONA GROUP RESEARCH & DEVELOPMENT, CO., LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Pressure Problem	714	714
Gas/Air Leak	481	481
No Display/Image	436	436
Adverse Event Without Identified Device or Use Problem	354	354
Display or Visual Feedback Problem	340	341
Failure to Power Up	296	296
Electrical /Electronic Property Problem	270	270
Output Problem	202	202
Break	194	194
Circuit Failure	178	178
No Visual Prompts/Feedback	175	175
Loss of Power	171	172
Gas Output Problem	167	168
Unexpected Shutdown	152	152
Leak/Splash	146	146
No Device Output	146	146
Decrease in Pressure	138	138
Increase in Pressure	134	134
Power Problem	129	129
Audible Prompt/Feedback Problem	119	119
Insufficient Flow or Under Infusion	119	119
Defective Component	108	108
Device Alarm System	99	99
Infusion or Flow Problem	90	90
Activation Failure	85	85
No Flow	83	83
Erratic or Intermittent Display	82	82
Improper Flow or Infusion	78	78
Intermittent Loss of Power	77	77
Communication or Transmission Problem	70	70
Noise, Audible	69	69
Free or Unrestricted Flow	58	58
Detachment of Device or Device Component	53	53
Corroded	53	53
Crack	53	53
Insufficient Information	52	52
Degraded	51	51
Inflation Problem	44	45
Excess Flow or Over-Infusion	44	44
Inaccurate Flow Rate	44	44
Restricted Flow rate	43	43
Incorrect, Inadequate or Imprecise Result or Readings	43	43
Fail-Safe Did Not Operate	42	42
Mechanical Problem	41	41
Defective Alarm	36	36
Key or Button Unresponsive/not Working	36	36
Complete Loss of Power	35	35
Component Missing	28	28
Defective Device	27	27
Material Deformation	26	26

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5428	5430
Air Embolism	241	241
Insufficient Information	106	110
No Consequences Or Impact To Patient	86	86
Cardiac Arrest	39	39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	33	33
Bradycardia	23	23
Pneumothorax	22	22
Bowel Perforation	14	14
Hemorrhage/Bleeding	13	13
Infiltration into Tissue	12	12
Hypothermia	12	12
Pulmonary Emphysema	10	10
Unspecified Respiratory Problem	9	9
Abdominal Pain	9	9
Stroke/CVA	9	9
Abdominal Distention	7	7
Embolism/Embolus	7	7
Low Oxygen Saturation	6	6
Unspecified Tissue Injury	6	6
Perforation	6	6
Burn(s)	6	6
Swelling/ Edema	5	5
Low Blood Pressure/ Hypotension	5	5
Asystole	5	5
Dyspnea	5	5
No Patient Involvement	5	5
Tachycardia	4	4
Skin Disorders	4	4
Ischemia Stroke	3	3
Respiratory Insufficiency	3	3
Partial thickness (Second Degree) Burn	3	3
Pain	3	3
Laceration(s)	3	3
Foreign Body In Patient	3	3
Hypoxia	2	2
Caustic/Chemical Burns	2	2
Hyperthermia	2	2
Arrhythmia	2	2
Mediastinal Shift	2	2
Paralysis	2	2
Respiratory Acidosis	2	2
Electrolyte Imbalance	2	2
Respiratory Arrest	2	2
Rupture	2	2
Airway Obstruction	2	2
Tissue Breakdown	2	2
Pulmonary Embolism	2	2
Unspecified Heart Problem	1	1
Hypovolemic Shock	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Northgate Technologies, Inc.	II	Feb-24-2021
2	Olympus Corporation of the Americas	I	Feb-18-2026
3	Olympus Corporation of the Americas	II	Mar-25-2024
4	Olympus Corporation of the Americas	I	Oct-18-2023