TPLC - Total Product Life Cycle

show TPLC since

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
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	450	450
Fracture	293	293
Material Twisted/Bent	251	251
Improper or Incorrect Procedure or Method	183	183
Adverse Event Without Identified Device or Use Problem	177	177
Off-Label Use	152	152
Retraction Problem	103	103
Detachment of Device or Device Component	103	103
Physical Resistance/Sticking	94	94
Use of Device Problem	44	44
Difficult to Remove	44	44
Material Separation	41	41
Material Perforation	40	40
Mechanical Problem	33	33
Material Split, Cut or Torn	25	25
Difficult to Advance	25	25
Device Damaged Prior to Use	24	24
Device Contamination with Chemical or Other Material	24	24
Dent in Material	21	21
Insufficient Information	21	21
Failure to Obtain Sample	19	19
Device-Device Incompatibility	18	18
Material Fragmentation	16	16
Failure to Advance	16	16
Material Puncture/Hole	14	14
Difficult to Open or Close	13	13
Difficult to Insert	12	12
Structural Problem	11	11
No Apparent Adverse Event	10	10
Material Deformation	10	10
Device Fell	9	9
Loss of or Failure to Bond	9	9
Device Markings/Labelling Problem	7	7
Positioning Problem	7	7
Mechanical Jam	7	7
Failure to Eject	6	6
Output Problem	6	6
Defective Device	6	6
Material Protrusion/Extrusion	5	5
Tear, Rip or Hole in Device Packaging	5	5
Separation Problem	5	5
Contamination	5	5
Unstable	5	5
Component Missing	5	5
Device Slipped	5	5
Leak/Splash	5	5
Dull, Blunt	5	5
Positioning Failure	5	5
Unintended Movement	4	4
No Display/Image	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1258	1258
Foreign Body In Patient	208	208
No Consequences Or Impact To Patient	125	125
Hemorrhage/Bleeding	87	87
No Known Impact Or Consequence To Patient	76	76
Insufficient Information	50	50
Pancreatitis	38	38
Gastrointestinal Hemorrhage	30	30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	23	23
Abdominal Pain	21	21
Fever	20	20
Pneumothorax	18	18
Pain	16	16
Unspecified Infection	15	15
Device Embedded In Tissue or Plaque	15	15
Peritonitis	15	15
No Patient Involvement	14	14
Hematoma	12	12
Perforation	11	11
Inflammation	9	9
No Code Available	8	8
Low Blood Pressure/ Hypotension	8	8
Unspecified Hepatic or Biliary Problem	7	7
Needle Stick/Puncture	7	7
Hypoxia	6	6
Unspecified Tissue Injury	6	6
Pneumonia	6	6
Respiratory Failure	5	5
Abscess	5	5
Air Embolism	5	5
Sepsis	5	5
Injury	5	5
Hemoptysis	4	4
Cough	4	4
Biliary Cirrhosis	4	4
Thrombocytopenia	4	4
Blood Loss	4	4
Dyspnea	3	3
Death	3	3
Vomiting	3	3
Septic Shock	3	3
Unspecified Gastrointestinal Problem	3	3
Cardiac Arrest	3	3
Fibrosis	3	3
Obstruction/Occlusion	3	3
Low Oxygen Saturation	3	3
Wheezing	2	2
Nausea	2	2
Exposure to Body Fluids	2	2
Discomfort	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