TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
No Display/Image	1308	1309
Erratic or Intermittent Display	725	725
Display or Visual Feedback Problem	698	698
Optical Problem	473	474
Poor Quality Image	344	345
Device Reprocessing Problem	309	309
Electrical /Electronic Property Problem	155	155
Break	100	101
Output Problem	80	80
Loose or Intermittent Connection	65	65
Failure to Power Up	60	62
Use of Device Problem	57	58
Image Display Error/Artifact	56	56
Failure to Run on Battery	54	54
Mechanical Problem	47	48
Insufficient Information	37	37
Device Handling Problem	33	33
Adverse Event Without Identified Device or Use Problem	33	33
Material Opacification	31	31
Mechanical Jam	29	29
Output below Specifications	26	26
Material Erosion	24	24
Intermittent Loss of Power	19	19
Appropriate Term/Code Not Available	19	19
Energy Output Problem	19	19
Detachment of Device or Device Component	18	18
Material Fragmentation	18	18
No Apparent Adverse Event	17	17
Connection Problem	16	16
Material Separation	15	15
Activation Failure	14	14
Defective Device	14	15
Fitting Problem	13	13
Loss of or Failure to Bond	11	11
Power Problem	11	11
Therapeutic or Diagnostic Output Failure	11	12
Material Integrity Problem	11	11
Intermittent Continuity	10	10
Battery Problem	10	11
Temperature Problem	10	10
Device Damaged Prior to Use	9	9
Physical Resistance/Sticking	8	8
Activation Problem	8	8
Material Deformation	7	7
Manufacturing, Packaging or Shipping Problem	7	7
Premature Discharge of Battery	7	7
No Visual Prompts/Feedback	7	7
Unexpected Shutdown	6	6
Device-Device Incompatibility	5	5
Product Quality Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3095	3098
Insufficient Information	421	423
Low Oxygen Saturation	26	26
Unspecified Tissue Injury	22	22
Cardiac Arrest	16	17
Foreign Body In Patient	12	12
Hemorrhage/Bleeding	11	11
Laceration(s)	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Unspecified Respiratory Problem	7	7
Hypoxia	7	7
Bradycardia	4	4
Respiratory Arrest	3	3
Airway Obstruction	3	3
Abrasion	3	3
Asystole	3	3
High Oxygen Saturation	2	2
Respiratory Failure	2	2
Abdominal Distention	2	2
Respiratory Insufficiency	2	2
Tooth Fracture	2	2
Loss of consciousness	2	2
Burn(s)	2	2
Skin Tears	2	2
Bronchospasm	2	2
Swelling/ Edema	2	2
Device Embedded In Tissue or Plaque	1	1
Lethargy	1	1
Low Blood Pressure/ Hypotension	1	1
Sore Throat	1	1
Tinnitus	1	1
Immunodeficiency	1	1
Cough	1	1
Shock	1	1
Choking	1	1
Pain	1	1
Cardiopulmonary Arrest	1	1
Discomfort	1	1
Vomiting	1	1
Obstruction/Occlusion	1	1
Laceration(s) of Esophagus	1	1
Crushing Injury	1	1
Diminished Pulse Pressure	1	1
Perforation	1	1
Exsanguination	1	1
Aspiration/Inhalation	1	1
Low Apgar Score	1	1
Adult Respiratory Distress Syndrome	1	1
Acoustic Shock	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 (Dongguan) Ltd.	I	Aug-01-2025
7	Intersurgical Inc	I	Jul-11-2025
8	Karl Storz Endoscopy	II	Dec-18-2023
9	TELEFLEX MEDICAL INC	II	Mar-23-2021
10	Verathon, Inc.	II	Jun-04-2024
11	Verathon, Inc.	III	Jul-30-2021