TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ALLOTROPE MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
CHECKPOINT SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
INOMED MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC XOMED, INC.
	SUBSTANTIALLY EQUIVALENT	3
NVISION BIOMEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
RETROPSOAS TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU HAISHEN MEDICAL DEVICE ASSOCIATES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	485	485
Incorrect, Inadequate or Imprecise Result or Readings	448	448
Unintended Deflation	157	157
Device Sensing Problem	146	146
Failure to Sense	121	121
False Negative Result	99	99
Inappropriate Audible Prompt/Feedback	92	92
Obstruction of Flow	81	81
Break	80	80
Leak/Splash	75	75
Unable to Obtain Readings	69	69
Adverse Event Without Identified Device or Use Problem	60	60
Noise, Audible	49	49
Failure to Power Up	35	35
False Positive Result	34	34
Sensing Intermittently	29	29
Inflation Problem	29	29
Connection Problem	28	28
Gas/Air Leak	27	27
Computer Software Problem	23	23
Circuit Failure	17	17
Application Program Freezes, Becomes Nonfunctional	17	17
Material Puncture/Hole	16	16
Partial Blockage	14	14
Material Protrusion/Extrusion	12	12
No Apparent Adverse Event	11	11
Fracture	11	11
Intermittent Continuity	11	11
Therapeutic or Diagnostic Output Failure	10	10
Intermittent Loss of Power	10	10
Material Too Soft/Flexible	7	7
Blocked Connection	7	7
Signal Artifact/Noise	7	7
Insufficient Information	6	6
Failure to Deflate	6	6
Defective Device	6	6
Failure to Unfold or Unwrap	6	6
Deformation Due to Compressive Stress	6	6
Problem with Software Installation	6	6
Display or Visual Feedback Problem	5	5
Detachment of Device or Device Component	5	5
Deflation Problem	5	5
Material Split, Cut or Torn	5	5
Fluid/Blood Leak	5	5
Failure to Read Input Signal	5	5
Electrical /Electronic Property Problem	4	4
Output Problem	4	4
Material Deformation	4	4
Migration or Expulsion of Device	4	4
Material Twisted/Bent	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1353	1353
No Consequences Or Impact To Patient	395	395
Unintended Extubation	230	230
Nerve Damage	73	73
No Known Impact Or Consequence To Patient	69	69
Airway Obstruction	55	55
Low Oxygen Saturation	47	47
Paralysis	25	25
Unspecified Tissue Injury	22	22
Extubate	20	20
Insufficient Information	18	18
No Patient Involvement	15	15
Hypoventilation	11	11
Hemorrhage/Bleeding	10	10
Bronchospasm	10	10
Unspecified Respiratory Problem	9	9
Hypoxia	9	9
Foreign Body In Patient	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Bradycardia	8	8
Swelling/ Edema	6	6
Injury	6	6
Burn(s)	6	6
Unspecified Infection	5	5
Low Blood Pressure/ Hypotension	5	5
Fatigue	5	5
Pain	5	5
Dyspnea	5	5
Obstruction/Occlusion	5	5
Scar Tissue	4	4
Cardiac Arrest	4	4
Sore Throat	3	3
Tachycardia	3	3
Pneumothorax	3	3
Speech Disorder	3	3
Cyanosis	3	3
Respiratory Arrest	3	3
Brain Injury	3	3
Ischemia	2	2
Paresthesia	2	2
Hypersensitivity/Allergic reaction	2	2
Arrhythmia	2	2
Irritation	2	2
Oversedation	2	2
Perforation of Esophagus	2	2
Apnea	2	2
Needle Stick/Puncture	2	2
Discomfort	2	2
Decreased Respiratory Rate	2	2
Dysphasia	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Xomed, Inc.	II	Jan-10-2024
2	Medtronic Xomed, Inc.	I	Sep-01-2022
3	Medtronic Xomed, Inc.	II	Mar-10-2022
4	Neurovision Medical Products Inc	II	Aug-23-2024
5	Neurovision Medical Products Inc	II	Aug-27-2020
6	Spes Medica	II	Jun-25-2021
7	Stryker Instruments Div. of Stryker Corporation	II	Oct-01-2019
8	Technomed Europe	II	Sep-12-2024
9	The Magstim Company Limited	II	Jan-15-2021