TPLC - Total Product Life Cycle

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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	5	5
Insufficient Information	3	3
Scratched Material	2	2
Material Fragmentation	2	2
Detachment of Device or Device Component	2	2
Device Operates Differently Than Expected	1	1
Accessory Incompatible	1	1
Break	1	1
Detachment Of Device Component	1	1
Component Incompatible	1	1
No Display/Image	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
Bowel Burn	10	10
Abdominal Pain	9	9
Bacterial Infection	9	9
No Known Impact Or Consequence To Patient	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