TPLC - Total Product Life Cycle

show TPLC since

Device	needle, aspiration and injection, disposable
Regulation Description	Manual surgical instrument for general use.
Product Code	GAA
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Contamination with Chemical or Other Material	216	216
Defective Component	172	172
Break	65	65
Adverse Event Without Identified Device or Use Problem	54	54
Contamination	48	48
Leak/Splash	39	39
Complete Blockage	27	27
Packaging Problem	25	25
Contamination /Decontamination Problem	22	22
Entrapment of Device	16	16
Device Markings/Labelling Problem	10	10
Fracture	7	7
Dull, Blunt	7	7
Delivered as Unsterile Product	7	7
Material Twisted/Bent	6	6
Tear, Rip or Hole in Device Packaging	5	5
Material Deformation	4	4
Material Discolored	4	4
Detachment of Device or Device Component	4	4
Fluid/Blood Leak	4	4
Activation, Positioning or Separation Problem	4	4
Illegible Information	4	4
Component Missing	4	4
Crack	3	3
Material Separation	3	3
Inaccurate Information	3	3
Connection Problem	3	3
Defective Device	3	3
Material Puncture/Hole	3	3
Device-Device Incompatibility	2	2
Contamination of Device Ingredient or Reagent	2	2
Application Network Problem	2	2
Failure to Advance	2	2
Difficult to Remove	2	2
Product Quality Problem	2	2
Appropriate Term/Code Not Available	2	2
Nonstandard Device	2	2
Migration	2	2
Loose or Intermittent Connection	2	2
Improper or Incorrect Procedure or Method	2	2
Disconnection	2	2
Positioning Failure	2	2
Unclear Information	2	2
Partial Blockage	2	2
Insufficient Information	1	1
Unintended Movement	1	1
Material Split, Cut or Torn	1	1
Ejection Problem	1	1
Suction Failure	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	536	536
Insufficient Information	60	60
No Known Impact Or Consequence To Patient	46	46
No Consequences Or Impact To Patient	33	33
No Patient Involvement	30	30
Foreign Body In Patient	27	27
Endophthalmitis	17	17
Pneumothorax	12	12
Eye Infections	5	5
Inflammation	5	5
Needle Stick/Puncture	5	5
Phlebitis	4	4
Unspecified Tissue Injury	4	4
Hemorrhage/Bleeding	4	4
Intraocular Infection	4	4
No Code Available	3	3
Bronchial Hemorrhage	3	3
Cough	3	3
Bradycardia	3	3
Low Blood Pressure/ Hypotension	2	2
Unspecified Infection	2	2
Injury	2	2
Nausea	1	1
Pain	1	1
Tachycardia	1	1
Urinary Retention	1	1
Visual Impairment	1	1
Vomiting	1	1
Device Embedded In Tissue or Plaque	1	1
Unspecified Eye / Vision Problem	1	1
Unintended Radiation Exposure	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Abdominal Pain	1	1
Cardiac Arrest	1	1
Macular Edema	1	1
Corneal Infiltrates	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aomori Olympus Co., Ltd.	II	Feb-05-2021
2	Hobbs Medical, Inc.	II	Oct-07-2022
3	INNOVATIVE TOMOGRAPHY PRODUCT GMBH	II	Jul-29-2021
4	M.D.L. S.r.l.	II	Sep-20-2021
5	North American Rescue LLC.	II	Sep-23-2021
6	Tytek Medical Inc	II	Sep-19-2023
7	Vitreq Bv	II	Jan-24-2020