TPLC - Total Product Life Cycle

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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
Defective Component	225	225
Device Contamination with Chemical or Other Material	222	223
Break	79	80
Adverse Event Without Identified Device or Use Problem	77	77
Contamination	59	60
Leak/Splash	48	49
Contamination /Decontamination Problem	35	35
Complete Blockage	27	27
Packaging Problem	26	26
Entrapment of Device	18	19
Device Markings/Labelling Problem	10	10
Dull, Blunt	9	9
Fracture	7	7
Detachment of Device or Device Component	7	8
Delivered as Unsterile Product	7	7
Material Twisted/Bent	7	7
Connection Problem	6	6
Tear, Rip or Hole in Device Packaging	5	5
Activation, Positioning or Separation Problem	4	4
Fluid/Blood Leak	4	4
Illegible Information	4	4
Material Puncture/Hole	4	4
Material Separation	4	5
Material Deformation	4	4
Component Missing	4	4
Material Discolored	4	4
Inaccurate Information	3	3
Nonstandard Device	3	3
Crack	3	3
Defective Device	3	5
Material Perforation	3	3
Improper or Incorrect Procedure or Method	2	2
Loose or Intermittent Connection	2	2
Application Network Problem	2	2
Appropriate Term/Code Not Available	2	2
Failure to Advance	2	2
Migration	2	2
Contamination of Device Ingredient or Reagent	2	2
Product Quality Problem	2	2
Partial Blockage	2	2
Positioning Failure	2	2
Degraded	2	2
Difficult to Remove	2	2
Unclear Information	2	2
Device Contaminated During Manufacture or Shipping	2	7
Device-Device Incompatibility	2	2
Disconnection	2	2
Material Fragmentation	1	1
Device Difficult to Setup or Prepare	1	1
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	640	648
Insufficient Information	72	73
No Known Impact Or Consequence To Patient	46	47
No Consequences Or Impact To Patient	33	33
No Patient Involvement	30	30
Foreign Body In Patient	29	30
Vitreous Floaters	20	20
Endophthalmitis	19	19
Pneumothorax	13	13
Needle Stick/Puncture	7	7
Eye Infections	6	6
Inflammation	5	5
Hemorrhage/Bleeding	4	4
Phlebitis	4	4
Unspecified Tissue Injury	4	4
Intraocular Infection	4	4
Cough	3	3
Bronchial Hemorrhage	3	3
No Code Available	3	3
Injury	2	2
Bradycardia	2	2
Unspecified Infection	2	2
Cardiac Arrest	1	1
Hemoptysis	1	1
Chest Pain	1	1
Pleural Effusion	1	1
Urinary Retention	1	1
Vomiting	1	1
Unspecified Eye / Vision Problem	1	1
Pain	1	3
Visual Impairment	1	1
Bone Fracture(s)	1	1
Nausea	1	1
Macular Edema	1	1
Tachycardia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Abdominal Pain	1	1
Low Blood Pressure/ Hypotension	1	1
Corneal Infiltrates	1	1
Device Embedded In Tissue or Plaque	1	1
Unintended Radiation Exposure	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