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	120	120
Device Markings/Labelling Problem	114	114
Device-Device Incompatibility	100	100
Delivered as Unsterile Product	52	52
Adverse Event Without Identified Device or Use Problem	37	37
Material Deformation	36	36
Crack	29	29
Material Twisted/Bent	22	22
Detachment of Device or Device Component	16	16
Fluid/Blood Leak	14	14
Material Separation	14	14
Mechanical Jam	12	12
Entrapment of Device	11	11
Material Integrity Problem	8	8
Contamination /Decontamination Problem	8	8
Packaging Problem	8	8
Device Contaminated During Manufacture or Shipping	4	4
Material Fragmentation	4	4
Contamination	3	3
Fracture	3	3
Device Slipped	2	2
Improper or Incorrect Procedure or Method	2	2
Defective Component	2	2
Use of Device Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Product Quality Problem	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
Missing Information	1	1
Component Misassembled	1	1
No Apparent Adverse Event	1	1
Misassembly by Users	1	1
Solder Joint Fracture	1	1
Material Rupture	1	1
Misassembled	1	1
Structural Problem	1	1
Positioning Failure	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Defective Device	1	3
Material Puncture/Hole	1	1
Material Erosion	1	1
Device Damaged Prior to Use	1	1
Mechanical Problem	1	1
Burst Container or Vessel	1	1
Component or Accessory Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	385	387
No Consequences Or Impact To Patient	133	133
Insufficient Information	24	24
Foreign Body In Patient	20	20
Abscess	7	7
Pain	7	7
Unspecified Infection	5	5
Hemorrhage/Bleeding	5	5
Device Embedded In Tissue or Plaque	4	4
No Patient Involvement	4	4
Hernia	4	4
Obstruction/Occlusion	4	4
Needle Stick/Puncture	4	4
Fistula	3	3
Wound Dehiscence	3	3
Failure to Anastomose	3	3
No Code Available	3	3
Inflammation	3	3
Pleural Effusion	3	3
Cardiac Tamponade	3	3
Post Operative Wound Infection	3	3
No Known Impact Or Consequence To Patient	3	3
Fever	2	2
Peritonitis	2	2
Blood Loss	2	2
Not Applicable	2	2
Abdominal Pain	2	2
Seroma	1	1
Incontinence	1	1
Vomiting	1	1
Perforation	1	1
Discomfort	1	1
Hematoma	1	1
Adhesion(s)	1	1
Sepsis	1	1
Nausea	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Pneumothorax	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