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	484	484
Incorrect, Inadequate or Imprecise Result or Readings	328	328
Device Sensing Problem	146	146
Unintended Deflation	133	133
Failure to Sense	120	120
Break	76	76
False Negative Result	75	75
Obstruction of Flow	73	73
Leak/Splash	73	73
Inappropriate Audible Prompt/Feedback	71	71
Unable to Obtain Readings	69	69
Adverse Event Without Identified Device or Use Problem	58	58
Noise, Audible	49	49
Failure to Power Up	29	29
Sensing Intermittently	29	29
Inflation Problem	28	28
Connection Problem	27	27
Gas/Air Leak	26	26
False Positive Result	24	24
Computer Software Problem	18	18
Material Puncture/Hole	16	16
Circuit Failure	14	14
Application Program Freezes, Becomes Nonfunctional	14	14
Partial Blockage	13	13
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
Insufficient Information	6	6
Defective Device	6	6
Deformation Due to Compressive Stress	6	6
Signal Artifact/Noise	6	6
Failure to Deflate	5	5
Display or Visual Feedback Problem	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
Detachment of Device or Device Component	4	4
Failure to Unfold or Unwrap	4	4
Material Deformation	4	4
Migration or Expulsion of Device	4	4
Tear, Rip or Hole in Device Packaging	3	3
Loose or Intermittent Connection	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1170	1170
No Consequences Or Impact To Patient	395	395
Unintended Extubation	200	200
No Known Impact Or Consequence To Patient	69	69
Nerve Damage	63	63
Airway Obstruction	53	53
Low Oxygen Saturation	42	42
Paralysis	22	22
Unspecified Tissue Injury	22	22
Extubate	20	20
Insufficient Information	18	18
No Patient Involvement	15	15
Hemorrhage/Bleeding	10	10
Hypoventilation	10	10
Unspecified Respiratory Problem	9	9
Bronchospasm	9	9
Foreign Body In Patient	9	9
Hypoxia	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Bradycardia	7	7
Swelling/ Edema	6	6
Burn(s)	6	6
Injury	6	6
Fatigue	5	5
Dyspnea	5	5
Low Blood Pressure/ Hypotension	5	5
Obstruction/Occlusion	5	5
Unspecified Infection	5	5
Scar Tissue	4	4
Cardiac Arrest	4	4
Pneumothorax	3	3
Brain Injury	3	3
Respiratory Arrest	3	3
Sore Throat	3	3
Tachycardia	3	3
Pain	3	3
Cyanosis	3	3
Paresis	2	2
Laceration(s)	2	2
Decreased Respiratory Rate	2	2
Discomfort	2	2
Needle Stick/Puncture	2	2
Oversedation	2	2
Irritation	2	2
Paresthesia	2	2
Dysphasia	2	2
Ischemia	2	2
Perforation of Esophagus	2	2
Apnea	2	2
Radiation Exposure, Unintended	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