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
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	485	485
Fracture	297	297
Material Twisted/Bent	262	262
Improper or Incorrect Procedure or Method	185	185
Adverse Event Without Identified Device or Use Problem	181	181
Off-Label Use	154	154
Detachment of Device or Device Component	114	114
Retraction Problem	105	105
Physical Resistance/Sticking	95	95
Material Separation	48	48
Use of Device Problem	44	44
Difficult to Remove	44	44
Material Perforation	42	42
Mechanical Problem	36	36
Material Split, Cut or Torn	27	27
Device Damaged Prior to Use	25	25
Difficult to Advance	25	25
Device Contamination with Chemical or Other Material	24	24
Dent in Material	21	21
Insufficient Information	21	21
Failure to Obtain Sample	20	20
Device-Device Incompatibility	18	18
Difficult to Open or Close	17	17
Material Fragmentation	16	16
Failure to Advance	16	16
Material Puncture/Hole	16	16
Difficult to Insert	13	13
Material Deformation	11	11
Structural Problem	11	11
Device Markings/Labelling Problem	10	10
No Apparent Adverse Event	10	10
Device Fell	9	9
Loss of or Failure to Bond	9	9
Mechanical Jam	8	8
Positioning Problem	7	7
Defective Device	7	7
Contamination	7	7
Output Problem	6	6
Unintended Movement	6	6
Failure to Eject	6	6
Material Integrity Problem	5	5
Material Protrusion/Extrusion	5	5
Leak/Splash	5	5
Dull, Blunt	5	5
Tear, Rip or Hole in Device Packaging	5	5
Component Missing	5	5
Separation Problem	5	5
Unstable	5	5
Device Slipped	5	5
Positioning Failure	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1343	1343
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	24	24
Abdominal Pain	21	21
Fever	20	20
Peritonitis	18	18
Pneumothorax	18	18
Pain	16	16
Device Embedded In Tissue or Plaque	15	15
Unspecified Infection	15	15
No Patient Involvement	14	14
Hematoma	12	12
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
Unspecified Tissue Injury	6	6
Pneumonia	6	6
Hypoxia	6	6
Air Embolism	5	5
Injury	5	5
Sepsis	5	5
Respiratory Failure	5	5
Cough	4	4
Thrombocytopenia	4	4
Low Oxygen Saturation	4	4
Blood Loss	4	4
Hemoptysis	4	4
Biliary Cirrhosis	4	4
Fibrosis	3	3
Obstruction/Occlusion	3	3
Dyspnea	3	3
Septic Shock	3	3
Death	3	3
Vomiting	3	3
Cardiac Arrest	3	3
Unspecified Gastrointestinal Problem	3	3
Confusion/ Disorientation	2	2
Laceration(s)	2	2
Nausea	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