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	617	618
Fracture	322	322
Material Twisted/Bent	293	293
Improper or Incorrect Procedure or Method	185	185
Adverse Event Without Identified Device or Use Problem	167	167
Detachment of Device or Device Component	141	142
Off-Label Use	137	137
Retraction Problem	109	110
Device Contamination with Chemical or Other Material	103	103
Physical Resistance/Sticking	103	103
Difficult to Remove	55	56
Material Separation	50	50
Material Perforation	48	48
Material Split, Cut or Torn	48	48
Mechanical Problem	42	42
Use of Device Problem	41	41
Material Puncture/Hole	39	39
Device Markings/Labelling Problem	36	36
Failure to Advance	35	35
Difficult to Advance	28	28
Failure to Obtain Sample	24	24
Device-Device Incompatibility	23	23
Dent in Material	22	22
Device Damaged Prior to Use	20	20
Material Fragmentation	20	20
Material Integrity Problem	20	20
Difficult to Open or Close	20	20
Material Deformation	17	17
Structural Problem	17	17
Difficult to Insert	16	16
Mechanical Jam	15	15
Insufficient Information	12	12
Contamination	12	12
Contamination /Decontamination Problem	11	11
Unintended Movement	10	10
No Apparent Adverse Event	10	10
Loss of or Failure to Bond	9	9
Leak/Splash	8	8
Unstable	8	8
Positioning Problem	8	8
Output Problem	7	7
Material Protrusion/Extrusion	7	7
Defective Device	7	7
Tear, Rip or Hole in Device Packaging	6	6
Dull, Blunt	6	6
Positioning Failure	6	6
Device Damaged by Another Device	6	6
Failure to Eject	6	6
Activation Failure	6	6
Device Fell	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1928	1930
Foreign Body In Patient	205	205
Hemorrhage/Bleeding	88	88
Insufficient Information	56	56
Pancreatitis	42	42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	36	37
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
Hypoxia	6	6
Unspecified Tissue Injury	6	6
Pneumonia	6	6
Needle Stick/Puncture	5	5
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
Inflammation	3	3
Obstruction/Occlusion	3	3
Hemoptysis	3	3
Unspecified Gastrointestinal Problem	3	3
Fibrosis	3	3
Septic Shock	3	3
Vomiting	3	3
Laceration(s)	3	3
Dyspnea	3	3
Bronchospasm	2	2
Perforation of Vessels	2	2
Bradycardia	2	2
Hemothorax	2	2
Respiratory Tract Infection	2	2
Discomfort	2	2
Confusion/ Disorientation	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