TPLC - Total Product Life Cycle

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Device	endoscopic bite block
Regulation Description	Endoscope and accessories.
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	31	31
Device Reprocessing Problem	15	15
Melted	10	10
Adverse Event Without Identified Device or Use Problem	8	8
Residue After Decontamination	8	8
Break	6	6
Contamination /Decontamination Problem	5	5
Crack	3	3
Deformation Due to Compressive Stress	3	3
Insufficient Information	2	2
Material Integrity Problem	2	2
Failure to Clean Adequately	2	2
Patient Device Interaction Problem	2	2
Problem with Sterilization	2	2
Material Deformation	2	2
Detachment of Device or Device Component	2	2
Device Contamination with Chemical or Other Material	2	2
Device Slipped	1	1
Device Contaminated During Manufacture or Shipping	1	1
Output Problem	1	1
Separation Failure	1	1
Unintended Movement	1	1
Contamination	1	1
Material Fragmentation	1	1
Fail-Safe Problem	1	1
Material Discolored	1	1
Use of Device Problem	1	1
Gas/Air Leak	1	1
Thermal Decomposition of Device	1	1
Protective Measures Problem	1	1
Output below Specifications	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	68	68
No Consequences Or Impact To Patient	9	9
Tooth Fracture	5	5
Hemorrhage/Bleeding	4	4
Foreign Body In Patient	3	3
Laceration(s)	3	3
Insufficient Information	2	2
Respiratory Insufficiency	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
No Code Available	1	1
Cardiac Arrest	1	1
No Known Impact Or Consequence To Patient	1	1
Rash	1	1
Needle Stick/Puncture	1	1
Cough	1	1
Swelling/ Edema	1	1
Airway Obstruction	1	1