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	2
LIMACA MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU LEAPMED HEALTHCARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	565	566
Fracture	285	285
Material Twisted/Bent	269	269
Improper or Incorrect Procedure or Method	170	170
Adverse Event Without Identified Device or Use Problem	162	162
Off-Label Use	136	136
Detachment of Device or Device Component	127	128
Retraction Problem	107	108
Physical Resistance/Sticking	101	101
Difficult to Remove	48	49
Material Separation	48	48
Material Perforation	43	43
Use of Device Problem	40	40
Mechanical Problem	40	40
Material Split, Cut or Torn	38	38
Device Contamination with Chemical or Other Material	37	37
Device Markings/Labelling Problem	29	29
Material Puncture/Hole	29	29
Difficult to Advance	26	26
Failure to Advance	25	25
Failure to Obtain Sample	24	24
Device-Device Incompatibility	23	23
Dent in Material	22	22
Device Damaged Prior to Use	20	20
Difficult to Open or Close	19	19
Material Fragmentation	18	18
Material Integrity Problem	18	18
Structural Problem	16	16
Difficult to Insert	14	14
Mechanical Jam	13	13
Material Deformation	12	12
Contamination	12	12
Insufficient Information	12	12
Contamination /Decontamination Problem	11	11
No Apparent Adverse Event	10	10
Unintended Movement	8	8
Loss of or Failure to Bond	8	8
Leak/Splash	8	8
Defective Device	7	7
Output Problem	7	7
Device Fell	6	6
Tear, Rip or Hole in Device Packaging	6	6
Failure to Eject	6	6
Dull, Blunt	6	6
Material Protrusion/Extrusion	5	5
Positioning Problem	5	5
Unstable	5	5
Positioning Failure	5	5
Component Missing	5	5
Activation Failure	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1675	1677
Foreign Body In Patient	192	192
Hemorrhage/Bleeding	83	83
Insufficient Information	53	53
Pancreatitis	42	42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	34	35
Gastrointestinal Hemorrhage	27	27
No Known Impact Or Consequence To Patient	21	21
Pneumothorax	20	20
Fever	19	19
Abdominal Pain	17	17
Peritonitis	17	17
Pain	14	14
Unspecified Infection	13	13
Hematoma	13	13
Perforation	10	10
Device Embedded In Tissue or Plaque	9	9
Unspecified Hepatic or Biliary Problem	9	9
Low Blood Pressure/ Hypotension	8	8
Abscess	7	7
Pneumonia	6	6
Hypoxia	6	6
Unspecified Tissue Injury	6	6
Sepsis	5	5
Respiratory Failure	5	5
Air Embolism	5	5
Cough	4	4
Biliary Cirrhosis	4	4
Thrombocytopenia	4	4
No Consequences Or Impact To Patient	4	4
Low Oxygen Saturation	4	4
Needle Stick/Puncture	4	4
Hemoptysis	3	3
Obstruction/Occlusion	3	3
Unspecified Gastrointestinal Problem	3	3
Fibrosis	3	3
Septic Shock	3	3
Vomiting	3	3
Dyspnea	3	3
Bronchospasm	2	2
Perforation of Vessels	2	2
Bradycardia	2	2
Hemothorax	2	2
Laceration(s)	2	2
Respiratory Tract Infection	2	2
Discomfort	2	2
Confusion/ Disorientation	2	2
Inflammation	2	2
Cyst(s)	2	2
Wheezing	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	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