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	105	105
Use of Device Problem	11	11
Material Fragmentation	6	6
Detachment of Device or Device Component	4	4
Insufficient Information	3	3
Failure to Deliver Energy	1	1
Material Split, Cut or Torn	1	1
No Display/Image	1	1
Accessory Incompatible	1	1
Therapeutic or Diagnostic Output Failure	1	1
Computer Software Problem	1	1
Fracture	1	1
Appropriate Term/Code Not Available	1	1
Melted	1	1
Component Incompatible	1	1
Overheating of Device	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	24	24
Abdominal Pain	14	14
Bacterial Infection	12	12
Bowel Perforation	12	12
Bowel Burn	11	11
Fever	10	10
Burn(s)	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Insufficient Information	9	9
Uterine Perforation	8	8
Hemorrhage/Bleeding	7	7
Pain	7	7
Abscess	6	6
Unspecified Infection	4	4
Sepsis	4	4
Necrosis	4	4
Foreign Body In Patient	4	4
Nausea	3	3
Hematoma	3	3
Intermenstrual Bleeding	3	3
Low Blood Pressure/ Hypotension	2	2
Organ Dehiscence	2	2
Vomiting	2	2
Cardiac Arrest	2	2
Pelvic Inflammatory Disease	2	2
Rupture	2	2
Adhesion(s)	2	2
Respiratory Arrest	2	2
Oversedation	1	1
Nerve Damage	1	1
Diarrhea	1	1
Localized Skin Lesion	1	1
Septic Shock	1	1
Induced Abortion	1	1
Urinary Retention	1	1
Vesicovaginal Fistula	1	1
Scar Tissue	1	1
Abdominal Cramps	1	1
Bradycardia	1	1
Sexually Transmitted Infection	1	1
Unspecified Tissue Injury	1	1
Abnormal Vaginal Discharge	1	1
Ascites	1	1
Weight Changes	1	1
Urinary Tract Infection	1	1
Fistula	1	1
Hypervolemia	1	1