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	287	287
Break	73	73
Material Separation	71	72
Adverse Event Without Identified Device or Use Problem	43	44
Detachment of Device or Device Component	24	24
Material Twisted/Bent	22	22
Material Fragmentation	20	20
Insufficient Information	16	16
Unraveled Material	15	15
Fracture	13	13
Material Deformation	10	10
Material Split, Cut or Torn	8	8
Deformation Due to Compressive Stress	8	8
Entrapment of Device	8	8
Device Contaminated During Manufacture or Shipping	7	7
Difficult to Advance	7	7
Unsealed Device Packaging	7	7
Device Damaged Prior to Use	5	5
Defective Device	5	5
Difficult to Remove	5	5
Device Damaged by Another Device	5	5
Microbial Contamination of Device	4	4
Difficult to Insert	4	4
Improper or Incorrect Procedure or Method	3	3
Physical Resistance/Sticking	3	3
Inadequate Lubrication	3	3
Migration	3	3
Material Frayed	2	2
Accessory Incompatible	2	2
Particulates	2	2
Tear, Rip or Hole in Device Packaging	2	2
Fluid/Blood Leak	1	1
Mechanical Jam	1	1
Loose or Intermittent Connection	1	1
Flaked	1	1
Failure to Advance	1	1
No Apparent Adverse Event	1	1
Product Quality Problem	1	1
Difficult or Delayed Positioning	1	1
Use of Device Problem	1	1
Scratched Material	1	1
Contamination /Decontamination Problem	1	1
Contamination	1	1
Collapse	1	1
Crack	1	1
Mechanical Problem	1	1
No Display/Image	1	1
Device-Device Incompatibility	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	449	449
Foreign Body In Patient	80	81
Insufficient Information	25	25
Hemorrhage/Bleeding	19	19
Pancreatitis	17	17
Perforation	12	12
Swelling/ Edema	12	12
Internal Organ Perforation	10	10
No Consequences Or Impact To Patient	7	7
Peritonitis	6	6
Perforation of Esophagus	4	4
Laceration(s) of Esophagus	4	4
Bacterial Infection	4	4
Device Embedded In Tissue or Plaque	4	4
Sepsis	2	2
Gastrointestinal Hemorrhage	2	2
Bowel Perforation	2	2
Laceration(s)	2	2
Pain	2	2
Unspecified Infection	1	1
Abdominal Pain	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Death	1	1
Inflammation	1	2
No Known Impact Or Consequence To Patient	1	1
Fever	1	1
Retroperitoneal Hemorrhage	1	1
No Patient Involvement	1	1
Vomiting	1	1
Biliary Cirrhosis	1	1
Unspecified Tissue Injury	1	1
Respiratory Failure	1	1
Fistula	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Incorporated	II	Sep-28-2022