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	75	75
Use of Device Problem	8	8
Material Separation	7	7
Insufficient Information	3	3
Scratched Material	2	2
Detachment of Device or Device Component	2	2
No Display/Image	2	2
Material Fragmentation	2	2
Break	2	2
Thermal Decomposition of Device	1	1
Detachment Of Device Component	1	1
Component Incompatible	1	1
Melted	1	1
Accessory Incompatible	1	1
Device Operates Differently Than Expected	1	1
Malposition of Device	1	1
Therapeutic or Diagnostic Output Failure	1	1
Appropriate Term/Code Not Available	1	1
Material Split, Cut or Torn	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
Bowel Burn	10	10
Abdominal Pain	9	9
Bacterial Infection	9	9
Fever	8	8
Burn(s)	5	5
Abscess	5	5
Pain	5	5
Bowel Perforation	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Uterine Perforation	4	4
Unspecified Infection	4	4
Nausea	3	3
Necrosis	3	3
Hemorrhage/Bleeding	3	3
Rupture	3	3
Device Embedded In Tissue or Plaque	2	2
Vomiting	2	2
No Consequences Or Impact To Patient	2	2
Organ Dehiscence	2	2
Pelvic Inflammatory Disease	2	2
Sepsis	2	2
Insufficient Information	2	2
Urinary Tract Infection	1	1
Scar Tissue	1	1
Nerve Damage	1	1
Oversedation	1	1
Bradycardia	1	1
Diarrhea	1	1
Fistula	1	1
Hematoma	1	1
Burn, Thermal	1	1
Weight Changes	1	1
Hypervolemia	1	1
Abnormal Vaginal Discharge	1	1
Vesicovaginal Fistula	1	1
Sexually Transmitted Infection	1	1
Unspecified Tissue Injury	1	1
Injury	1	1
Needle Stick/Puncture	1	1