TPLC - Total Product Life Cycle

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Device	coagulator-cutter, endoscopic, unipolar (and accessories)
Regulation Description	Unipolar endoscopic coagulator-cutter and accessories.
Product Code	KNF
Regulation Number	884.4160
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	87	87
Break	25	25
Detachment of Device or Device Component	16	16
Material Separation	5	5
Insufficient Device Problem Information	4	6
Fracture	3	3
Failure to Cut	3	3
Sparking	3	3
Fitting Problem	2	2
Lack of Effect	2	2
Mechanical Problem	2	2
Material Disintegration	2	2
Excessive Heating	2	2
Melted	2	2
Overheating of Device	2	2
Material Integrity Problem	1	1
Material Fragmentation	1	1
Connection Problem	1	1
Material Rupture	1	1
Fire	1	1
Physical Resistance/Sticking	1	1
Smoking	1	1
Dull, Blunt	1	1
Material Frayed	1	1
Patient Device Interaction Problem	1	1
Material Deformation	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	56	56
Pelvic Pain	33	33
Fever	30	30
Unspecified Infection	22	22
Unspecified Reproductive System or Breast Problem	15	15
Abnormal Vaginal Discharge	14	14
Insufficient Information	11	11
Bacteremia	8	8
Menstrual Irregularities	7	7
Sepsis	6	6
Burn(s)	6	6
Hemorrhage/Blood Loss/Bleeding	5	5
Leiomyosarcoma	4	4
Urinary Tract Infection	4	4
Urinary Retention	4	4
Partial thickness (Second Degree) Burn	3	5
Bowel Burn	3	3
Foreign Body In Patient	3	3
Laceration(s)	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Unintended Radiation Exposure	2	2
Intermenstrual Bleeding	2	2
No Consequences Or Impact To Patient	2	2
Constipation	2	2
Bowel Perforation	2	2
Necrosis	1	1
Tachycardia	1	1
Headache	1	1
Hormonal Imbalance	1	1
Dyspnea	1	1
Chills	1	1
Electric Shock	1	1
Uterine Perforation	1	1
Low Blood Pressure/ Hypotension	1	1
Inflammation	1	1
Unspecified Tissue Injury	1	1
Thrombocytopenia	1	1
Abdominal Pain	1	1