TPLC - Total Product Life Cycle

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Device	biopsy needle
Regulation Description	Gastroenterology-urology biopsy instrument.
Product Code	FCG
Regulation Number	876.1075
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIBBINSTRUMENTS AB
	SUBSTANTIALLY EQUIVALENT	1
COOK IRELAND LTD.
	SUBSTANTIALLY EQUIVALENT	3
FINEMEDIX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K231267 ClearTip
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	503	503
Fracture	300	300
Material Twisted/Bent	267	267
Improper or Incorrect Procedure or Method	187	187
Adverse Event Without Identified Device or Use Problem	182	182
Off-Label Use	154	154
Detachment of Device or Device Component	118	118
Retraction Problem	108	108
Physical Resistance/Sticking	96	96
Material Separation	49	49
Difficult to Remove	45	45
Use of Device Problem	44	44
Material Perforation	42	42
Mechanical Problem	38	38
Material Split, Cut or Torn	27	27
Device Damaged Prior to Use	25	25
Device Contamination with Chemical or Other Material	25	25
Difficult to Advance	25	25
Dent in Material	21	21
Failure to Obtain Sample	21	21
Insufficient Information	21	21
Device-Device Incompatibility	19	19
Failure to Advance	18	18
Material Puncture/Hole	18	18
Difficult to Open or Close	17	17
Material Fragmentation	16	16
Material Deformation	14	14
Difficult to Insert	13	13
Structural Problem	12	12
Device Markings/Labelling Problem	12	12
Loss of or Failure to Bond	10	10
Mechanical Jam	10	10
No Apparent Adverse Event	10	10
Device Fell	9	9
Contamination	8	8
Defective Device	7	7
Positioning Problem	7	7
Leak/Splash	7	7
Unintended Movement	6	6
Failure to Eject	6	6
Output Problem	6	6
Tear, Rip or Hole in Device Packaging	5	5
Material Protrusion/Extrusion	5	5
Material Integrity Problem	5	5
Separation Problem	5	5
Dull, Blunt	5	5
Unstable	5	5
Device Slipped	5	5
Component Missing	5	5
Positioning Failure	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1393	1393
Foreign Body In Patient	211	211
No Consequences Or Impact To Patient	125	125
Hemorrhage/Bleeding	89	89
No Known Impact Or Consequence To Patient	76	76
Insufficient Information	54	54
Pancreatitis	38	38
Gastrointestinal Hemorrhage	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
Abdominal Pain	21	21
Fever	20	20
Pneumothorax	18	18
Peritonitis	18	18
Pain	16	16
Device Embedded In Tissue or Plaque	15	15
Unspecified Infection	15	15
No Patient Involvement	14	14
Hematoma	13	13
Perforation	11	11
Unspecified Hepatic or Biliary Problem	9	9
Inflammation	9	9
No Code Available	8	8
Low Blood Pressure/ Hypotension	8	8
Abscess	7	7
Needle Stick/Puncture	7	7
Hypoxia	6	6
Unspecified Tissue Injury	6	6
Pneumonia	6	6
Respiratory Failure	5	5
Air Embolism	5	5
Sepsis	5	5
Injury	5	5
Hemoptysis	4	4
Cough	4	4
Biliary Cirrhosis	4	4
Low Oxygen Saturation	4	4
Thrombocytopenia	4	4
Blood Loss	4	4
Dyspnea	3	3
Death	3	3
Septic Shock	3	3
Vomiting	3	3
Fibrosis	3	3
Unspecified Gastrointestinal Problem	3	3
Cardiac Arrest	3	3
Obstruction/Occlusion	3	3
Confusion/ Disorientation	2	2
Exposure to Body Fluids	2	2
Discomfort	2	2
Respiratory Tract Infection	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Aomori Olympus Co., Ltd.	II	Feb-05-2021
2	Bard Peripheral Vascular Inc	II	Sep-20-2024
3	Cook Medical Incorporated	II	May-16-2024
4	Covidien Llc	II	Aug-05-2020
5	MEDLINE INDUSTRIES, LP - Northfield	II	Sep-06-2024
6	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
7	Olympus Corporation of the Americas	III	May-19-2023