TPLC - Total Product Life Cycle

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Device	endoscopic guidewire, gastroenterology-urology
Regulation Description	Endoscope and accessories.
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	294	294
Material Separation	87	87
Break	75	75
Adverse Event Without Identified Device or Use Problem	51	51
Detachment of Device or Device Component	25	25
Material Twisted/Bent	19	19
Material Fragmentation	19	19
Insufficient Information	13	13
Material Deformation	12	12
Unraveled Material	11	11
Deformation Due to Compressive Stress	10	10
Appropriate Term/Code Not Available	9	9
Fracture	9	9
Entrapment of Device	8	8
Difficult to Advance	8	8
Device Contaminated During Manufacture or Shipping	7	7
Positioning Failure	7	7
Device Damaged by Another Device	5	5
Positioning Problem	5	5
Device Damaged Prior to Use	5	5
Material Split, Cut or Torn	5	5
Difficult to Remove	4	4
Microbial Contamination of Device	4	4
Defective Device	4	4
Difficult to Insert	4	4
Unsealed Device Packaging	4	4
Use of Device Problem	4	4
Accessory Incompatible	3	3
Physical Resistance/Sticking	3	3
Improper or Incorrect Procedure or Method	3	3
Contamination /Decontamination Problem	2	2
Particulates	2	2
Inadequate Lubrication	2	2
Material Integrity Problem	1	1
Contamination	1	1
Scratched Material	1	1
Collapse	1	1
Crack	1	1
Difficult or Delayed Positioning	1	1
Product Quality Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Material Protrusion/Extrusion	1	1
No Apparent Adverse Event	1	1
Migration	1	1
Device-Device Incompatibility	1	1
Device Slipped	1	1
Flaked	1	1
Loose or Intermittent Connection	1	1
Material Frayed	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	388	388
No Consequences Or Impact To Patient	85	85
Foreign Body In Patient	65	65
Insufficient Information	24	24
Pancreatitis	14	14
Hemorrhage/Bleeding	13	13
Swelling/ Edema	12	12
Perforation	11	11
No Known Impact Or Consequence To Patient	10	10
No Code Available	7	7
No Patient Involvement	7	7
Pain	7	7
Device Embedded In Tissue or Plaque	6	6
Tingling	4	4
Laceration(s) of Esophagus	4	4
Peritonitis	4	4
Discomfort	4	4
Bacterial Infection	4	4
Perforation of Esophagus	3	3
Twitching	3	3
Sepsis	2	2
Gastrointestinal Hemorrhage	2	2
No Information	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
Fever	1	1
Retroperitoneal Hemorrhage	1	1
Septic Shock	1	1
Vomiting	1	1
Biliary Cirrhosis	1	1
Internal Organ Perforation	1	1
Respiratory Failure	1	1
Fistula	1	1