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
Erratic or Intermittent Display	765	765
No Display/Image	429	429
Display or Visual Feedback Problem	407	407
Break	185	185
Optical Problem	175	175
Poor Quality Image	139	139
Electrical /Electronic Property Problem	77	77
Connection Problem	46	46
Image Display Error/Artifact	45	45
Loose or Intermittent Connection	39	39
Insufficient Information	25	25
Failure to Power Up	24	24
Use of Device Problem	24	24
Appropriate Term/Code Not Available	20	20
Detachment of Device or Device Component	19	19
Output Problem	16	16
Material Fragmentation	15	15
Intermittent Loss of Power	15	15
Mechanical Problem	15	15
Battery Problem	14	14
Therapeutic or Diagnostic Output Failure	14	14
Defective Device	14	14
Defective Component	14	14
Optical Obstruction	13	13
Overheating of Device	12	12
Material Separation	11	11
Activation Failure	10	10
Device Damaged Prior to Use	10	10
Failure to Disconnect	10	10
Fitting Problem	10	10
Temperature Problem	8	8
Power Problem	6	6
No Visual Prompts/Feedback	6	6
Electrical Shorting	6	6
Intermittent Continuity	6	6
Improper or Incorrect Procedure or Method	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Failure to Run on Battery	6	6
Display Difficult to Read	5	5
Device Dislodged or Dislocated	5	5
Crack	5	5
Fracture	5	5
Device-Device Incompatibility	5	5
Application Program Freezes, Becomes Nonfunctional	4	4
Component Incompatible	4	4
Corroded	4	4
Environmental Compatibility Problem	4	4
Sharp Edges	4	4
Continuous Firing	4	4
Charging Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1258	1258
No Consequences Or Impact To Patient	476	476
Insufficient Information	186	186
No Known Impact Or Consequence To Patient	126	126
No Patient Involvement	112	112
Unspecified Tissue Injury	16	16
Low Oxygen Saturation	14	14
Cardiac Arrest	13	13
Laceration(s)	12	12
Foreign Body In Patient	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Injury	8	8
Extubate	6	6
Hemorrhage/Bleeding	6	6
No Information	6	6
Aspiration/Inhalation	6	6
Death	5	5
Bradycardia	4	4
Sore Throat	3	3
Unspecified Respiratory Problem	3	3
Abrasion	3	3
Tooth Fracture	3	3
Hypoxia	3	3
Device Embedded In Tissue or Plaque	2	2
Airway Obstruction	2	2
Tissue Damage	2	2
Shock	2	2
Missing Value Reason	2	2
Burn(s)	2	2
Respiratory Arrest	2	2
No Code Available	2	2
Respiratory Distress	2	2
Choking	1	1
Dyspnea	1	1
Cardiopulmonary Arrest	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
Skin Tears	1	1
Skin Irritation	1	1
Acoustic Shock	1	1
Tinnitus	1	1
Hypoventilation	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Failure	1	1
Unintended Extubation	1	1
High Blood Pressure/ Hypertension	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