TPLC - Total Product Life Cycle

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Device	endoscope, ac-powered and accessories
Regulation Description	Endoscope and accessories.
Product Code	GCP
Regulation Number	876.1500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	238	238
Detachment of Device or Device Component	52	52
Crack	19	19
Material Twisted/Bent	18	18
Adverse Event Without Identified Device or Use Problem	17	17
Fracture	17	17
Mechanical Problem	14	14
Contamination	13	13
Thermal Decomposition of Device	9	9
Poor Quality Image	9	9
Material Integrity Problem	8	8
Material Deformation	7	7
Difficult to Open or Close	6	6
Material Fragmentation	6	6
Optical Problem	6	6
Melted	6	6
Physical Resistance/Sticking	6	6
Device Reprocessing Problem	5	5
Obstruction of Flow	5	5
Component Missing	5	5
Labelling, Instructions for Use or Training Problem	5	5
Loose or Intermittent Connection	5	5
Mechanical Jam	4	4
Dent in Material	4	4
Material Separation	3	3
Sparking	3	3
Scratched Material	3	3
Device Markings/Labelling Problem	2	2
Image Display Error/Artifact	2	2
Material Frayed	2	2
Difficult to Fold, Unfold or Collapse	2	2
Entrapment of Device	2	2
Electrical /Electronic Property Problem	2	3
No Display/Image	2	2
Material Disintegration	2	2
Degraded	2	2
Corroded	2	2
Failure to Seal	2	2
Device Handling Problem	1	1
Activation Failure	1	1
Unintended Movement	1	1
Material Split, Cut or Torn	1	1
Device Fell	1	1
Output Problem	1	1
Optical Distortion	1	1
Activation Problem	1	1
Failure to Clean Adequately	1	1
Device Contaminated During Manufacture or Shipping	1	1
Defective Component	1	1
Electro-Static Discharge	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	398	398
Foreign Body In Patient	15	15
Burn(s)	7	7
Sepsis	5	5
Urinary Tract Infection	5	5
Bacterial Infection	4	4
No Consequences Or Impact To Patient	4	4
Urethral Stenosis/Stricture	3	3
No Known Impact Or Consequence To Patient	3	3
Insufficient Information	3	3
Device Embedded In Tissue or Plaque	3	3
Urinary Incontinence	2	2
Hemorrhage/Bleeding	2	2
Internal Organ Perforation	2	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hyponatremia	1	1
No Code Available	1	1
Perforation	1	1
Blood Loss	1	1
Rupture	1	1
No Patient Involvement	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Olympus Corporation of the Americas	II	Nov-08-2024