TPLC - Total Product Life Cycle

show TPLC since

Device	coagulator, laparoscopic, unipolar (and accessories)
Regulation Description	Unipolar endoscopic coagulator-cutter and accessories.
Product Code	HFG
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	115	115
Use of Device Problem	12	12
Material Fragmentation	6	6
Detachment of Device or Device Component	4	4
Insufficient Device Problem Information	2	2
No Display/Image	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Melted	1	1
Failure to Deliver Energy	1	1
No Device Output	1	1
Accessory Incompatible	1	1
Fracture	1	1
Overheating of Device	1	1
Component Incompatible	1	1
Computer Software Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24	24
Burn(s)	15	15
Abdominal Pain	14	14
Bacterial Infection	12	12
Bowel Perforation	12	12
Fever	11	11
Bowel Burn	11	11
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	10	10
Uterine Perforation	10	10
Pain	9	9
Insufficient Information	9	9
Hemorrhage/Blood Loss/Bleeding	7	7
Abscess	6	6
Sepsis	5	5
Necrosis	4	4
Pelvic Pain	4	4
Intermenstrual Bleeding	4	4
Foreign Body In Patient	4	4
Unspecified Infection	4	4
Nausea	3	3
Hematoma	3	3
Adhesion(s)	2	2
Rupture	2	2
Organ Dehiscence	2	2
Low Blood Pressure/ Hypotension	2	2
Respiratory Arrest	2	2
Cardiac Arrest	2	2
Pelvic Inflammatory Disease	2	2
Vomiting	2	2
Superficial (First Degree) Burn	1	1
Urinary Tract Infection	1	1
Vesicovaginal Fistula	1	1
Sexually Transmitted Infection	1	1
Pleural Effusion	1	1
Abdominal Cramps	1	1
Septic Shock	1	1
Diarrhea	1	1
Scar Tissue	1	1
Weight Changes	1	1
Localized Skin Lesion	1	1
Oversedation	1	1
Induced Abortion	1	1
Bladder Dysfunction	1	1
Abnormal Vaginal Discharge	1	1
Fistula	1	1
Ascites	1	1
Nerve Damage	1	1
Unspecified Tissue Injury	1	1
Hypervolemia	1	1
Urinary Retention	1	1