TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
VENNER MEDICAL (SINGAPORE) PTE LTD
	SUBSTANTIALLY EQUIVALENT	1
1. K191602 APA Oxy Blade

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	1035	1035
Erratic or Intermittent Display	849	849
Display or Visual Feedback Problem	476	476
Optical Problem	289	289
Break	186	186
Poor Quality Image	152	152
Electrical /Electronic Property Problem	100	100
Image Display Error/Artifact	54	54
Failure to Power Up	53	53
Use of Device Problem	51	51
Connection Problem	48	48
Loose or Intermittent Connection	40	40
Failure to Run on Battery	37	37
Mechanical Problem	36	36
Insufficient Information	33	33
Appropriate Term/Code Not Available	28	28
Device Handling Problem	23	23
Detachment of Device or Device Component	21	21
Material Opacification	18	18
Output Problem	18	18
Device Damaged Prior to Use	18	18
Material Erosion	17	17
Material Separation	17	17
Defective Device	16	16
Material Fragmentation	15	15
Therapeutic or Diagnostic Output Failure	15	15
Intermittent Loss of Power	15	15
Battery Problem	14	14
Defective Component	14	14
Adverse Event Without Identified Device or Use Problem	14	14
Optical Obstruction	13	13
Overheating of Device	12	12
Device Reprocessing Problem	12	12
Fitting Problem	11	11
Failure to Disconnect	10	10
Manufacturing, Packaging or Shipping Problem	10	10
Activation Failure	10	10
Temperature Problem	9	9
Material Integrity Problem	8	8
Crack	6	6
No Visual Prompts/Feedback	6	6
Improper or Incorrect Procedure or Method	6	6
Electrical Shorting	6	6
Intermittent Continuity	6	6
Power Problem	6	6
Display Difficult to Read	5	5
Unexpected Shutdown	5	5
Device-Device Incompatibility	5	5
Device Dislodged or Dislocated	5	5
Fracture	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2075	2075
No Consequences Or Impact To Patient	476	476
Insufficient Information	320	320
No Known Impact Or Consequence To Patient	126	126
No Patient Involvement	112	112
Unspecified Tissue Injury	18	18
Low Oxygen Saturation	17	17
Cardiac Arrest	17	17
Laceration(s)	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Foreign Body In Patient	9	9
Injury	8	8
Extubate	6	6
Hemorrhage/Bleeding	6	6
No Information	6	6
Aspiration/Inhalation	6	6
Death	5	5
Hypoxia	4	4
Bradycardia	4	4
Airway Obstruction	3	3
Sore Throat	3	3
Respiratory Arrest	3	3
Unspecified Respiratory Problem	3	3
Abrasion	3	3
Tooth Fracture	3	3
Device Embedded In Tissue or Plaque	2	2
Skin Tears	2	2
Tissue Damage	2	2
Shock	2	2
Missing Value Reason	2	2
Burn(s)	2	2
No Code Available	2	2
Respiratory Distress	2	2
High Oxygen Saturation	2	2
Dyspnea	1	1
Choking	1	1
Cardiopulmonary Arrest	1	1
Vomiting	1	1
Asystole	1	1
Obstruction/Occlusion	1	1
Swelling/ Edema	1	1
Laceration(s) of Esophagus	1	1
Crushing Injury	1	1
Perforation	1	1
Exsanguination	1	1
Skin Irritation	1	1
Acoustic Shock	1	1
Tinnitus	1	1
Respiratory Insufficiency	1	1
Hypoventilation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Jun-24-2022
2	Covidien	II	Aug-22-2024
3	Covidien	I	Aug-21-2024
4	Covidien	I	Nov-02-2023
5	Covidien	II	Nov-01-2023
6	Flexicare Medical Ltd.	II	Jan-13-2020
7	Karl Storz Endoscopy	II	Dec-18-2023
8	King Systems Corp. dba Ambu, Inc.	I	Feb-04-2020
9	Medtronic, PLC	II	Feb-10-2020
10	TELEFLEX MEDICAL INC	II	Mar-23-2021
11	TELEFLEX MEDICAL INC	II	Jul-28-2020
12	TELEFLEX MEDICAL INC	II	Feb-07-2020
13	Verathon, Inc.	II	Jun-04-2024
14	Verathon, Inc.	III	Jul-30-2021
15	Verathon, Inc.	I	Jul-10-2020
16	Verathon, Inc.	II	Mar-11-2020