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	1
GUANGZHOU T.K MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PALLIARE LTD.
	SUBSTANTIALLY EQUIVALENT	4
PREMIUM MEDICAL TECHNOLOGY LLC
	SUBSTANTIALLY EQUIVALENT	1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
	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
W.O.M. WORLD OF MEDICINE GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Pressure Problem	452	452
No Display/Image	335	335
Adverse Event Without Identified Device or Use Problem	320	320
Electrical /Electronic Property Problem	271	271
Failure to Power Up	270	270
Gas/Air Leak	221	221
Display or Visual Feedback Problem	207	207
Loss of Power	151	151
No Visual Prompts/Feedback	136	136
Break	134	134
Output Problem	124	124
No Device Output	110	110
Power Problem	110	110
Gas Output Problem	106	106
Audible Prompt/Feedback Problem	104	104
Leak/Splash	99	99
Defective Component	96	96
Decrease in Pressure	94	94
Unexpected Shutdown	84	84
Increase in Pressure	79	79
Device Alarm System	76	76
Intermittent Loss of Power	66	66
Erratic or Intermittent Display	63	63
Circuit Failure	59	59
Insufficient Flow or Under Infusion	54	54
Free or Unrestricted Flow	54	54
No Flow	52	52
Infusion or Flow Problem	50	50
Noise, Audible	48	48
Defective Device	48	48
Insufficient Information	45	45
Communication or Transmission Problem	44	44
Fail-Safe Did Not Operate	43	43
Inflation Problem	41	41
Incorrect, Inadequate or Imprecise Result or Readings	39	39
Improper Flow or Infusion	37	37
Inaccurate Flow Rate	37	37
Excess Flow or Over-Infusion	37	37
Material Fragmentation	32	32
Key or Button Unresponsive/not Working	31	31
Mechanical Problem	29	29
Detachment of Device or Device Component	27	27
Complete Loss of Power	26	26
Defective Alarm	23	23
Restricted Flow rate	21	21
Connection Problem	18	18
Corroded	18	18
Contamination	17	17
Backflow	16	16
Therapeutic or Diagnostic Output Failure	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3432	3432
No Consequences Or Impact To Patient	303	303
Air Embolism	191	191
Insufficient Information	93	93
No Known Impact Or Consequence To Patient	49	49
Cardiac Arrest	33	33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	29	29
No Patient Involvement	23	23
Bradycardia	23	23
Injury	22	22
Pneumothorax	13	13
Bowel Perforation	13	13
Infiltration into Tissue	12	12
Hypothermia	11	11
Embolism/Embolus	10	10
No Code Available	10	10
Hemorrhage/Bleeding	10	10
Abdominal Pain	8	8
Abdominal Distention	7	7
Pulmonary Emphysema	7	7
Unspecified Respiratory Problem	7	7
Stroke/CVA	6	6
Burn(s)	6	6
Perforation	5	5
Swelling/ Edema	5	5
Unspecified Tissue Injury	5	5
Low Oxygen Saturation	5	5
Dyspnea	5	5
Skin Disorders	4	4
Tachycardia	4	4
Low Blood Pressure/ Hypotension	4	4
Patient Problem/Medical Problem	4	4
Respiratory Insufficiency	3	3
Death	3	3
Arrhythmia	3	3
Laceration(s)	3	3
Foreign Body In Patient	3	3
Ischemia Stroke	3	3
Partial thickness (Second Degree) Burn	2	2
Caustic/Chemical Burns	2	2
Hypoxia	2	2
Asystole	2	2
Hyperthermia	2	2
Pain	2	2
Pulmonary Embolism	2	2
Swelling	2	2
Paralysis	2	2
Fever	2	2
Electrolyte Imbalance	2	2
Respiratory Arrest	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Northgate Technologies, Inc.	II	Feb-24-2021
2	Olympus Corporation of the Americas	II	Mar-25-2024
3	Olympus Corporation of the Americas	I	Oct-18-2023
4	Richard Wolf GmbH	II	Jul-27-2020