TPLC - Total Product Life Cycle

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Device	cannula, surgical, general & plastic surgery
Regulation Description	Manual surgical instrument for general use.
Product Code	GEA
Regulation Number	878.4800
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	130	132
Device Markings/Labelling Problem	114	114
Device-Device Incompatibility	113	113
Delivered as Unsterile Product	57	57
Adverse Event Without Identified Device or Use Problem	39	39
Material Deformation	38	38
Crack	29	29
Material Twisted/Bent	27	27
Detachment of Device or Device Component	17	17
Mechanical Jam	16	16
Material Separation	16	16
Fluid/Blood Leak	14	14
Entrapment of Device	11	11
Material Integrity Problem	8	8
Contamination /Decontamination Problem	8	8
Packaging Problem	8	8
Material Fragmentation	5	5
Device Contaminated During Manufacture or Shipping	4	4
Fracture	4	4
Leak/Splash	3	3
Contamination	3	3
Use of Device Problem	3	3
Product Quality Problem	3	3
Device Slipped	2	2
Improper or Incorrect Procedure or Method	2	2
Defective Component	2	2
Solder Joint Fracture	2	2
Device Contamination with Chemical or Other Material	2	2
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
Increase in Pressure	1	1
Missing Information	1	1
Component Misassembled	1	1
No Apparent Adverse Event	1	1
Misassembly by Users	1	1
Material Rupture	1	1
Misassembled	1	1
Structural Problem	1	1
Positioning Failure	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Scratched Material	1	1
Defective Device	1	3
Unintended Movement	1	1
Material Puncture/Hole	1	1
Material Erosion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	420	424
No Consequences Or Impact To Patient	133	133
Insufficient Information	25	25
Foreign Body In Patient	21	21
Pain	9	9
Abscess	7	7
Unspecified Infection	6	6
Hemorrhage/Bleeding	5	5
Device Embedded In Tissue or Plaque	4	4
No Patient Involvement	4	4
Hernia	4	4
Needle Stick/Puncture	4	4
Obstruction/Occlusion	4	4
Fistula	3	3
Failure to Anastomose	3	3
Pleural Effusion	3	3
No Known Impact Or Consequence To Patient	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
Peritonitis	2	2
Blood Loss	2	2
Fever	2	2
Not Applicable	2	2
Incontinence	1	1
Seroma	1	1
Perforation	1	1
Hematoma	1	1
Vomiting	1	1
Adhesion(s)	1	1
Discomfort	1	1
Sepsis	1	1
Nausea	1	1
Pneumothorax	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Ectopic Pregnancy	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	Sklar Instruments	II	Jan-16-2025
5	TeDan Surgical Innovations LLC	II	May-01-2020