TPLC - Total Product Life Cycle

show TPLC since

Device	coagulator, laparoscopic, unipolar (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	78	78
Use of Device Problem	8	8
Material Separation	7	7
Insufficient Information	3	3
Material Fragmentation	3	3
Detachment of Device or Device Component	3	3
Break	2	2
No Display/Image	2	2
Scratched Material	2	2
Material Split, Cut or Torn	1	1
Malposition of Device	1	1
Accessory Incompatible	1	1
Therapeutic or Diagnostic Output Failure	1	1
Thermal Decomposition of Device	1	1
Device Operates Differently Than Expected	1	1
Appropriate Term/Code Not Available	1	1
Melted	1	1
Component Incompatible	1	1
Detachment Of Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13	13
No Known Impact Or Consequence To Patient	12	12
Abdominal Pain	10	10
Bowel Burn	10	10
Fever	10	10
Bacterial Infection	9	9
Bowel Perforation	6	6
Abscess	6	6
Pain	6	6
Uterine Perforation	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Burn(s)	5	5
Unspecified Infection	4	4
Nausea	3	3
Sepsis	3	3
Necrosis	3	3
Hemorrhage/Bleeding	3	3
Rupture	3	3
Insufficient Information	3	3
Device Embedded In Tissue or Plaque	2	2
No Consequences Or Impact To Patient	2	2
Organ Dehiscence	2	2
Vomiting	2	2
Pelvic Inflammatory Disease	2	2
Hematoma	2	2
Diarrhea	1	1
Nerve Damage	1	1
Septic Shock	1	1
Foreign Body In Patient	1	1
Needle Stick/Puncture	1	1
Injury	1	1
Scar Tissue	1	1
Vesicovaginal Fistula	1	1
Oversedation	1	1
Bradycardia	1	1
Sexually Transmitted Infection	1	1
Unspecified Tissue Injury	1	1
Burn, Thermal	1	1
Abnormal Vaginal Discharge	1	1
Fistula	1	1
Urinary Tract Infection	1	1
Hypervolemia	1	1
Weight Changes	1	1