TPLC - Total Product Life Cycle

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Device	endoscopic guidewire, gastroenterology-urology
Definition	To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
Product Code	OCY
Regulation Number	876.1500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Peeled/Delaminated	316	316
Material Separation	84	84
Break	72	72
Adverse Event Without Identified Device or Use Problem	53	53
Detachment of Device or Device Component	27	27
Positioning Problem	20	20
Material Twisted/Bent	19	19
Material Fragmentation	18	18
Fracture	17	17
Material Deformation	11	11
Unraveled Material	11	11
Deformation Due to Compressive Stress	10	10
Entrapment of Device	10	10
Difficult to Advance	10	10
Appropriate Term/Code Not Available	9	9
Insufficient Information	9	9
Positioning Failure	7	7
Difficult to Remove	6	6
Improper or Incorrect Procedure or Method	5	5
Off-Label Use	5	5
Physical Resistance/Sticking	5	5
Device Damaged Prior to Use	5	5
Unsealed Device Packaging	5	5
Defective Device	5	5
Device Damaged by Another Device	5	5
Use of Device Problem	5	5
Device Contaminated During Manufacture or Shipping	4	4
Microbial Contamination of Device	4	4
Material Too Rigid or Stiff	4	4
Flaked	3	3
Difficult to Insert	3	3
Contamination /Decontamination Problem	3	3
Accessory Incompatible	3	3
Material Split, Cut or Torn	3	3
Particulates	2	2
Material Integrity Problem	2	2
Inadequate Lubrication	2	2
Mechanical Jam	2	2
Scratched Material	1	1
Product Quality Problem	1	1
Collapse	1	1
Tear, Rip or Hole in Device Packaging	1	1
Crack	1	1
Material Protrusion/Extrusion	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Device Dislodged or Dislocated	1	1
Loose or Intermittent Connection	1	1
Device-Device Incompatibility	1	1
Material Frayed	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	341	341
No Consequences Or Impact To Patient	158	158
Foreign Body In Patient	51	51
No Known Impact Or Consequence To Patient	23	23
Insufficient Information	23	23
No Patient Involvement	13	13
Swelling/ Edema	12	12
Pancreatitis	11	11
Perforation	11	11
Hemorrhage/Bleeding	10	10
No Code Available	8	8
Device Embedded In Tissue or Plaque	8	8
Pain	7	7
Internal Organ Perforation	5	5
Tingling	4	4
Laceration(s) of Esophagus	4	4
Discomfort	4	4
Bacterial Infection	4	4
No Information	3	3
Twitching	3	3
Sepsis	2	2
Gastrointestinal Hemorrhage	2	2
Perforation of Esophagus	2	2
Inflammation	2	2
Laceration(s)	2	2
Abdominal Pain	1	1
Air Embolism	1	1
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Death	1	1
Bowel Perforation	1	1
Abrasion	1	1
Peritonitis	1	1
Fever	1	1
Retroperitoneal Hemorrhage	1	1
Septic Shock	1	1
Vomiting	1	1
Biliary Cirrhosis	1	1
Respiratory Failure	1	1
Fistula	1	1