TPLC - Total Product Life Cycle

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Device	cannula, surgical, general & plastic surgery
Product Code	GEA
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	132	132
Device Markings/Labelling Problem	114	114
Device-Device Incompatibility	97	97
Adverse Event Without Identified Device or Use Problem	45	45
Delivered as Unsterile Product	45	45
Crack	31	31
Material Deformation	30	30
Fluid/Blood Leak	20	20
Material Twisted/Bent	20	20
Detachment of Device or Device Component	17	17
Material Separation	14	14
Mechanical Jam	12	12
Entrapment of Device	10	10
Contamination /Decontamination Problem	10	10
Material Integrity Problem	8	8
Device Contaminated During Manufacture or Shipping	5	5
Physical Resistance/Sticking	5	5
Material Fragmentation	5	5
Device Contamination with Chemical or Other Material	5	5
Temperature Problem	2	2
Device Slipped	2	2
Improper or Incorrect Procedure or Method	2	2
Material Puncture/Hole	2	2
Defective Component	2	2
Contamination	2	2
Fracture	2	2
Product Quality Problem	2	2
Inadequate User Interface	1	1
Dull, Blunt	1	1
Difficult to Open or Close	1	1
Complete Loss of Power	1	1
Connection Problem	1	1
Nonstandard Device	1	1
Appropriate Term/Code Not Available	1	1
Protective Measures Problem	1	1
Missing Information	1	1
Component Misassembled	1	1
No Apparent Adverse Event	1	1
Tear, Rip or Hole in Device Packaging	1	1
Partial Blockage	1	1
Device Handling Problem	1	1
Misassembly by Users	1	1
Packaging Problem	1	1
Solder Joint Fracture	1	1
Material Rupture	1	1
Misassembled	1	1
Structural Problem	1	1
Improper Flow or Infusion	1	1
Failure to Align	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	353	355
No Consequences Or Impact To Patient	166	166
Insufficient Information	22	22
Foreign Body In Patient	20	20
No Known Impact Or Consequence To Patient	16	16
Not Applicable	13	13
Pain	9	9
No Patient Involvement	8	8
Unspecified Infection	7	7
Abscess	7	7
Hemorrhage/Bleeding	5	5
Hernia	5	5
Device Embedded In Tissue or Plaque	4	4
Failure to Anastomose	4	4
Hematoma	4	4
Obstruction/Occlusion	4	4
Needle Stick/Puncture	4	4
Fistula	3	3
Pleural Effusion	3	3
Seroma	3	3
Fever	3	3
Post Operative Wound Infection	3	3
Cardiac Tamponade	3	3
Inflammation	3	3
No Code Available	3	3
Wound Dehiscence	3	3
Abdominal Pain	3	3
Burn(s)	2	2
Peritonitis	2	2
Blood Loss	2	2
Sepsis	2	2
Injury	1	1
Incontinence	1	1
Perforation	1	1
Vomiting	1	1
Discomfort	1	1
Adhesion(s)	1	1
Nausea	1	1
Pneumothorax	1	1
Bradycardia	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Ectopic Pregnancy	1	1
Thromboembolism	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unintended Radiation Exposure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CLINICAL LASERTHERMIA SYSTEMS AB	II	Jun-04-2021
2	Cardinal Health 200, LLC	II	Mar-09-2020
3	Genicon, Inc.	II	Jun-05-2020
4	TeDan Surgical Innovations LLC	II	May-01-2020