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	122	124
Device-Device Incompatibility	84	84
Delivered as Unsterile Product	55	55
Device Markings/Labelling Problem	53	53
Adverse Event Without Identified Device or Use Problem	36	36
Material Deformation	36	36
Material Twisted/Bent	25	25
Crack	22	22
Detachment of Device or Device Component	15	15
Mechanical Jam	14	14
Fluid/Blood Leak	13	13
Material Separation	10	10
Entrapment of Device	9	9
Material Integrity Problem	9	9
Packaging Problem	7	7
Device Contaminated During Manufacture or Shipping	5	5
Leak/Splash	4	4
Material Fragmentation	4	4
Use of Device Problem	4	4
Fracture	4	4
Solder Joint Fracture	3	3
Product Quality Problem	3	3
Device Slipped	2	2
Unintended Movement	2	2
Improper or Incorrect Procedure or Method	2	2
Contamination	2	2
Dull, Blunt	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
Device Contamination with Chemical or Other Material	1	1
Misassembly by Users	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
Defective Component	1	1
Material Puncture/Hole	1	1
Mechanical Problem	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	423	427
Insufficient Information	25	25
Foreign Body In Patient	17	17
Pain	9	9
Unspecified Infection	7	7
Hemorrhage/Bleeding	7	7
Abscess	5	5
Needle Stick/Puncture	4	4
Device Embedded In Tissue or Plaque	4	4
Abdominal Pain	3	3
Wound Dehiscence	3	3
Inflammation	3	3
Obstruction/Occlusion	3	3
Cardiac Tamponade	3	3
Post Operative Wound Infection	3	3
Pleural Effusion	3	3
Hernia	3	3
Peritonitis	2	2
Failure to Anastomose	2	2
Unspecified Tissue Injury	2	2
Fistula	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Ectopic Pregnancy	1	1
Pneumothorax	1	1
Nausea	1	1
Hematoma	1	1
Perforation	1	1
Fever	1	1
Paralysis	1	1
Seroma	1	1
Vomiting	1	1
Discomfort	1	1
Swelling/ Edema	1	1
Unintended Radiation Exposure	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CLINICAL LASERTHERMIA SYSTEMS AB	II	Jun-04-2021
2	Sklar Instruments	II	Jan-16-2025