TPLC - Total Product Life Cycle

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Device	endoscopic bite block
Definition	To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.
Product Code	MNK
Regulation Number	876.1500
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	27	27
Adverse Event Without Identified Device or Use Problem	11	11
Break	6	6
Crack	3	3
Defective Component	3	3
Device Contamination with Chemical or Other Material	2	2
Material Integrity Problem	2	2
Device Contaminated During Manufacture or Shipping	1	1
Separation Failure	1	1
Contamination /Decontamination Problem	1	1
Detachment of Device or Device Component	1	1
Output Problem	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Device Fell	1	1
Material Fragmentation	1	1
Melted	1	1
Difficult to Remove	1	1
Device Reprocessing Problem	1	1
Contamination	1	1
Device Slipped	1	1
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	22	22
No Consequences Or Impact To Patient	12	12
Tooth Fracture	8	8
Laceration(s)	5	5
Injury	4	4
Hemorrhage/Bleeding	3	3
Hypersensitivity/Allergic reaction	2	2
No Known Impact Or Consequence To Patient	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
Swelling/ Edema	1	1
Abrasion	1	1
Fever	1	1
Sore Throat	1	1
Low Oxygen Saturation	1	1
Foreign Body In Patient	1	1