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	442	442
Detachment Of Device Component	378	378
Material Separation	124	124
Break	108	108
Adverse Event Without Identified Device or Use Problem	64	64
Detachment of Device or Device Component	31	31
Fracture	28	28
Positioning Problem	23	23
Material Fragmentation	22	22
Migration or Expulsion of Device	20	20
Material Twisted/Bent	19	19
Unraveled Material	19	19
Material Deformation	18	18
Difficult to Advance	12	12
Entrapment of Device	11	11
Improper or Incorrect Procedure or Method	11	11
Deformation Due to Compressive Stress	10	10
Device Damaged by Another Device	10	10
Flaked	9	9
Insufficient Information	9	9
Appropriate Term/Code Not Available	9	9
Device Damaged Prior to Use	8	8
Off-Label Use	8	8
Difficult to Remove	8	8
Material Frayed	7	7
Positioning Failure	7	7
Material Integrity Problem	6	6
Device Contaminated During Manufacture or Shipping	6	6
Use of Device Problem	6	6
Physical Resistance/Sticking	5	5
Unsealed Device Packaging	5	5
Defective Device	5	5
Material Too Rigid or Stiff	5	5
Bent	5	5
Device Operates Differently Than Expected	4	4
Device Dislodged or Dislocated	4	4
Material Disintegration	4	4
Microbial Contamination of Device	4	4
Device Contamination with Chemical or Other Material	4	4
Device-Device Incompatibility	4	4
Difficult to Insert	4	4
Accessory Incompatible	3	3
Material Split, Cut or Torn	3	3
Contamination /Decontamination Problem	3	3
Material Protrusion/Extrusion	3	3
Failure to Advance	2	2
Migration	2	2
No Apparent Adverse Event	2	2
Mechanical Jam	2	2
Scratched Material	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	687	687
No Clinical Signs, Symptoms or Conditions	341	341
No Known Impact Or Consequence To Patient	100	100
Foreign Body In Patient	77	77
Device Embedded In Tissue or Plaque	31	31
No Patient Involvement	28	28
Perforation	24	24
Insufficient Information	23	23
No Code Available	16	16
Swelling/ Edema	12	12
Hemorrhage/Bleeding	11	11
Pancreatitis	11	11
Pain	8	8
Internal Organ Perforation	6	6
Inflammation	5	5
No Information	4	4
Laceration(s) of Esophagus	4	4
Tingling	4	4
Discomfort	4	4
Bacterial Infection	4	4
Foreign body, removal of	3	3
Twitching	3	3
Gastrointestinal Hemorrhage	2	2
Sepsis	2	2
Perforation of Esophagus	2	2
Blood Loss	2	2
Fever	2	2
Hemostasis	2	2
Laceration(s)	2	2
Hematuria	1	1
Bowel Perforation	1	1
Abrasion	1	1
Death	1	1
Peritonitis	1	1
Retroperitoneal Hemorrhage	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Septic Shock	1	1
Vomiting	1	1
Nonresorbable materials, unretrieved in body	1	1
Surgical procedure, additional	1	1
Biliary Cirrhosis	1	1
Dysphasia	1	1
Unspecified Infection	1	1
Air Embolism	1	1
Respiratory Failure	1	1
Fistula	1	1
Abdominal Pain	1	1