TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BIBBINSTRUMENTS AB
	SUBSTANTIALLY EQUIVALENT	1
COOK IRELAND LTD.
	SUBSTANTIALLY EQUIVALENT	3
FINEMEDIX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LIMACA MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU LEAPMED HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
USHARE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	434	434
Fracture	283	283
Material Twisted/Bent	232	232
Improper or Incorrect Procedure or Method	166	166
Adverse Event Without Identified Device or Use Problem	163	163
Off-Label Use	142	142
Retraction Problem	106	106
Physical Resistance/Sticking	88	88
Detachment of Device or Device Component	79	79
Difficult to Remove	46	46
Material Perforation	41	41
Material Separation	38	38
Use of Device Problem	37	37
Mechanical Problem	33	33
Difficult to Advance	26	26
Device Contamination with Chemical or Other Material	24	24
Device Damaged Prior to Use	21	21
Insufficient Information	20	20
Failure to Obtain Sample	18	18
Device-Device Incompatibility	17	17
Dent in Material	16	16
Material Deformation	16	16
Failure to Advance	15	15
Material Split, Cut or Torn	13	13
Material Puncture/Hole	13	13
Material Fragmentation	12	12
Device Fell	12	12
Structural Problem	11	11
Difficult to Insert	11	11
No Apparent Adverse Event	10	10
Output Problem	8	8
Positioning Problem	8	8
Activation, Positioning or Separation Problem	7	7
Device Markings/Labelling Problem	7	7
Defective Device	7	7
Defective Component	6	6
Failure to Eject	6	6
Mechanical Jam	6	6
Loss of or Failure to Bond	6	6
Material Protrusion/Extrusion	5	5
Tear, Rip or Hole in Device Packaging	5	5
Difficult to Open or Close	5	5
Loose or Intermittent Connection	5	5
Separation Problem	5	5
Unstable	5	5
Device Slipped	5	5
Leak/Splash	5	5
Component Missing	5	5
Unsealed Device Packaging	4	4
Contamination	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	982	982
No Consequences Or Impact To Patient	243	243
Foreign Body In Patient	217	217
No Known Impact Or Consequence To Patient	134	134
Hemorrhage/Bleeding	67	67
Insufficient Information	45	45
Gastrointestinal Hemorrhage	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	23	23
Pancreatitis	23	23
Device Embedded In Tissue or Plaque	20	20
Abdominal Pain	18	18
No Patient Involvement	18	18
Pain	18	18
Pneumothorax	18	18
Fever	17	17
Unspecified Infection	15	15
Peritonitis	14	14
No Code Available	12	12
Hematoma	12	12
Perforation	11	11
Abscess	10	10
Needle Stick/Puncture	10	10
Inflammation	9	9
Low Blood Pressure/ Hypotension	8	8
Injury	8	8
Unspecified Hepatic or Biliary Problem	7	7
Pneumonia	7	7
Blood Loss	7	7
Hypoxia	6	6
Unspecified Tissue Injury	6	6
Hemoptysis	5	5
Sepsis	5	5
Respiratory Failure	5	5
Air Embolism	5	5
Cough	4	4
Thrombocytopenia	4	4
Radiation Exposure, Unintended	4	4
Death	4	4
Obstruction/Occlusion	3	3
Biliary Cirrhosis	3	3
Cardiac Arrest	3	3
Bradycardia	3	3
Unspecified Gastrointestinal Problem	3	3
Fibrosis	3	3
Septic Shock	3	3
Vomiting	3	3
Low Oxygen Saturation	3	3
Dyspnea	3	3
Bronchospasm	2	2
Perforation of Vessels	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Aomori Olympus Co., Ltd.	II	Feb-05-2021
2	Cook Medical Incorporated	II	May-16-2024
3	Covidien Llc	II	Aug-05-2020
4	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
5	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
6	Olympus Corporation of the Americas	III	May-19-2023