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	289	289
Material Separation	74	74
Break	68	68
Adverse Event Without Identified Device or Use Problem	51	51
Detachment of Device or Device Component	27	27
Positioning Problem	20	20
Material Twisted/Bent	19	19
Fracture	16	16
Material Fragmentation	15	15
Material Deformation	11	11
Deformation Due to Compressive Stress	10	10
Entrapment of Device	10	10
Unraveled Material	9	9
Difficult to Advance	9	9
Appropriate Term/Code Not Available	9	9
Insufficient Information	8	8
Positioning Failure	7	7
Difficult to Remove	6	6
Off-Label Use	5	5
Unsealed Device Packaging	5	5
Defective Device	5	5
Use of Device Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Device Damaged by Another Device	5	5
Physical Resistance/Sticking	5	5
Device Damaged Prior to Use	4	4
Microbial Contamination of Device	4	4
Material Too Rigid or Stiff	4	4
Difficult to Insert	3	3
Flaked	3	3
Contamination /Decontamination Problem	3	3
Device Contaminated During Manufacture or Shipping	2	2
Material Integrity Problem	2	2
Mechanical Jam	2	2
Accessory Incompatible	2	2
Particulates	2	2
Inadequate Lubrication	2	2
Material Split, Cut or Torn	2	2
Migration	1	1
Scratched Material	1	1
No Apparent Adverse Event	1	1
Loose or Intermittent Connection	1	1
Product Quality Problem	1	1
Crack	1	1
Material Frayed	1	1
Material Protrusion/Extrusion	1	1
Device Dislodged or Dislocated	1	1
Device-Device Incompatibility	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	304	304
No Consequences Or Impact To Patient	158	158
Foreign Body In Patient	48	48
No Known Impact Or Consequence To Patient	23	23
Insufficient Information	19	19
No Patient Involvement	13	13
Swelling/ Edema	12	12
Pancreatitis	11	11
Perforation	11	11
Hemorrhage/Bleeding	8	8
No Code Available	8	8
Device Embedded In Tissue or Plaque	8	8
Pain	7	7
Internal Organ Perforation	4	4
Tingling	4	4
Bacterial Infection	4	4
Discomfort	4	4
Laceration(s) of Esophagus	4	4
No Information	3	3
Twitching	3	3
Sepsis	2	2
Inflammation	2	2
Laceration(s)	2	2
Perforation of Esophagus	2	2
Respiratory Failure	1	1
Bowel Perforation	1	1
Peritonitis	1	1
Gastrointestinal Hemorrhage	1	1
Septic Shock	1	1
Biliary Cirrhosis	1	1
Death	1	1
Fever	1	1
Fistula	1	1
Unspecified Infection	1	1
Abdominal Pain	1	1
Abrasion	1	1
Air Embolism	1	1