TPLC - Total Product Life Cycle

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Device	accessories, photographic, for endoscope (exclude light sources)
Product Code	FEM
Regulation Number	876.1500
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Display or Visual Feedback Problem	185	185
Break	135	135
Sparking	25	25
Moisture Damage	24	24
Detachment of Device or Device Component	21	21
Smoking	17	17
Device-Device Incompatibility	16	16
Mechanical Problem	12	12
Thermal Decomposition of Device	12	12
Unintended Movement	11	11
Use of Device Problem	11	11
Loss of Power	10	10
Device Contaminated During Manufacture or Shipping	9	9
Fire	9	9
Difficult to Open or Close	9	9
Melted	8	8
Material Deformation	8	8
Degraded	8	8
Detachment Of Device Component	6	6
Device Operational Issue	6	6
Failure to Power Up	6	6
Device Damaged Prior to Use	5	5
Poor Quality Image	5	5
Device Fell	5	5
Device Emits Odor	5	5
Electrical /Electronic Property Problem	4	4
Mechanical Jam	4	4
Corroded	4	4
Loose or Intermittent Connection	4	4
Overheating of Device	4	4
Appropriate Term/Code Not Available	4	4
Device Operates Differently Than Expected	4	4
Scratched Material	4	4
Insufficient Information	4	4
Crack	4	4
Contamination /Decontamination Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Temperature Problem	3	3
Difficult or Delayed Separation	3	3
Unintended Collision	3	3
Disconnection	3	3
Defective Device	3	3
Defective Component	3	3
Electrical Power Problem	3	3
Battery Problem	2	2
Misassembled	2	2
Device Contamination with Chemical or Other Material	2	2
Power Problem	2	2
Difficult to Advance	2	2
Fracture	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	341	341
No Known Impact Or Consequence To Patient	38	38
No Consequences Or Impact To Patient	37	37
No Information	33	33
No Patient Involvement	20	20
Injury	7	7
Insufficient Information	7	7
Not Applicable	6	6
Unspecified Tissue Injury	4	4
Electric Shock	3	3
Bruise/Contusion	3	3
Patient Problem/Medical Problem	2	2
Shock	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
Sprain	1	1
Bowel Perforation	1	1
Burn, Thermal	1	1
Burn(s)	1	1
Swelling	1	1
Numbness	1	1
Laceration(s)	1	1
Pain	1	1
Hyperextension	1	1
Swelling/ Edema	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ambu Inc.	II	Sep-22-2023
2	Olympus America Inc.	II	Mar-05-2012
3	Olympus Corporation of the Americas	II	Jul-17-2019