TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
VENNER MEDICAL (SINGAPORE) PTE LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Erratic or Intermittent Display	799	799
No Display/Image	444	444
Display or Visual Feedback Problem	438	438
Optical Problem	205	205
Break	185	185
Poor Quality Image	143	143
Electrical /Electronic Property Problem	83	83
Use of Device Problem	48	48
Connection Problem	47	47
Image Display Error/Artifact	45	45
Loose or Intermittent Connection	39	39
Insufficient Information	28	28
Appropriate Term/Code Not Available	28	28
Failure to Power Up	24	24
Device Handling Problem	23	23
Detachment of Device or Device Component	20	20
Mechanical Problem	18	18
Output Problem	16	16
Defective Device	16	16
Material Fragmentation	15	15
Intermittent Loss of Power	15	15
Battery Problem	14	14
Adverse Event Without Identified Device or Use Problem	14	14
Therapeutic or Diagnostic Output Failure	14	14
Defective Component	14	14
Optical Obstruction	13	13
Material Erosion	13	13
Overheating of Device	12	12
Material Separation	12	12
Material Opacification	12	12
Device Damaged Prior to Use	11	11
Fitting Problem	11	11
Activation Failure	10	10
Failure to Disconnect	10	10
Temperature Problem	9	9
Manufacturing, Packaging or Shipping Problem	7	7
Failure to Run on Battery	7	7
Electrical Shorting	6	6
No Visual Prompts/Feedback	6	6
Power Problem	6	6
Intermittent Continuity	6	6
Improper or Incorrect Procedure or Method	6	6
Crack	5	5
Fracture	5	5
Display Difficult to Read	5	5
Device Dislodged or Dislocated	5	5
Device-Device Incompatibility	5	5
Product Quality Problem	4	4
Application Program Freezes, Becomes Nonfunctional	4	4
Component Incompatible	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1390	1390
No Consequences Or Impact To Patient	476	476
Insufficient Information	227	227
No Known Impact Or Consequence To Patient	126	126
No Patient Involvement	112	112
Unspecified Tissue Injury	18	18
Cardiac Arrest	16	16
Low Oxygen Saturation	14	14
Laceration(s)	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Foreign Body In Patient	9	9
Injury	8	8
Hemorrhage/Bleeding	6	6
Extubate	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
Tooth Fracture	3	3
Abrasion	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
Respiratory Distress	2	2
No Code Available	2	2
Choking	1	1
Cardiopulmonary Arrest	1	1
Dyspnea	1	1
Asystole	1	1
Vomiting	1	1
Swelling/ Edema	1	1
Laceration(s) of Esophagus	1	1
Crushing Injury	1	1
Obstruction/Occlusion	1	1
Exsanguination	1	1
Perforation	1	1
Acoustic Shock	1	1
Skin Irritation	1	1
Tinnitus	1	1
Unintended Extubation	1	1
Low Blood Pressure/ Hypotension	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