TPLC - Total Product Life Cycle

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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
Fracture	1	1
Accessory Incompatible	1	1
Melted	1	1
Computer Software Problem	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Failure to Deliver Energy	1	1
No Display/Image	1	1
No Device Output	1	1
Component Incompatible	1	1
Overheating of Device	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
Unspecified Infection	4	4
Foreign Body In Patient	4	4
Intermenstrual Bleeding	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
Vomiting	2	2
Pelvic Inflammatory Disease	2	2
Cardiac Arrest	2	2
Superficial (First Degree) Burn	1	1
Weight Changes	1	1
Urinary Retention	1	1
Oversedation	1	1
Pleural Effusion	1	1
Abdominal Cramps	1	1
Abnormal Vaginal Discharge	1	1
Diarrhea	1	1
Induced Abortion	1	1
Urinary Tract Infection	1	1
Vesicovaginal Fistula	1	1
Sexually Transmitted Infection	1	1
Hypervolemia	1	1
Bladder Dysfunction	1	1
Septic Shock	1	1
Nerve Damage	1	1
Scar Tissue	1	1
Fistula	1	1
Unspecified Tissue Injury	1	1
Ascites	1	1
Bradycardia	1	1