TPLC - Total Product Life Cycle

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Device	colonoscope and accessories, flexible/rigid
Regulation Description	Endoscope and accessories.
Definition	To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code	FDF
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACTUATED MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	1
BPENDO, LLC
	SUBSTANTIALLY EQUIVALENT	1
ERA ENDOSCOPY S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
GI VIEW LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU AGS MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUMENDI, LLC
	SUBSTANTIALLY EQUIVALENT	3
MOTUS GI MEDICAL TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	3
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
PENTAX OF AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
SANESO INC.
	SUBSTANTIALLY EQUIVALENT	1
SMART MEDICAL SYSTEMS LTD.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Clean Adequately	9390	9390
Break	4592	4592
No Display/Image	2684	2684
Microbial Contamination of Device	2667	2667
Erratic or Intermittent Display	2261	2261
Optical Obstruction	2193	2193
Fluid/Blood Leak	1985	1985
Device Reprocessing Problem	1964	1964
Obstruction of Flow	1942	1942
Communication or Transmission Problem	1804	1804
Detachment of Device or Device Component	1229	1229
Contamination	775	775
Optical Distortion	758	758
Unintended Movement	449	449
Poor Quality Image	433	433
Display or Visual Feedback Problem	378	378
Contamination /Decontamination Problem	352	352
Device Contamination with Chemical or Other Material	297	297
Adverse Event Without Identified Device or Use Problem	288	288
Material Split, Cut or Torn	211	211
Thermal Decomposition of Device	181	181
Loose or Intermittent Connection	167	167
Component Missing	130	130
Mechanical Problem	121	121
Image Display Error/Artifact	98	98
Electrical /Electronic Property Problem	89	89
Partial Blockage	86	86
Output Problem	86	86
Leak/Splash	76	76
Residue After Decontamination	76	76
Crack	76	76
Optical Problem	71	71
Fracture	68	68
Physical Resistance/Sticking	64	64
Failure to Power Up	58	58
Complete Blockage	57	57
Connection Problem	51	51
Material Deformation	47	47
Melted	41	41
Corroded	38	38
Incomplete or Inadequate Connection	38	38
Burst Container or Vessel	38	38
Material Puncture/Hole	35	35
Degraded	34	34
Moisture Damage	34	34
Collapse	32	32
Mechanical Jam	32	32
Material Integrity Problem	32	32
Suction Problem	32	32
Defective Component	31	31

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	35620	35620
No Consequences Or Impact To Patient	432	432
Insufficient Information	267	267
No Known Impact Or Consequence To Patient	190	190
Hemorrhage/Bleeding	161	161
No Patient Involvement	88	88
Bowel Perforation	79	79
Perforation	75	75
Laceration(s)	33	33
Pain	24	24
Abdominal Pain	22	22
Fever	18	18
Foreign Body In Patient	18	18
Diarrhea	15	15
Bacterial Infection	14	14
Abrasion	12	12
Internal Organ Perforation	12	12
Injury	12	12
Unspecified Tissue Injury	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Unspecified Gastrointestinal Problem	10	10
Hematoma	9	9
Electric Shock	9	9
Unspecified Infection	8	8
Device Embedded In Tissue or Plaque	8	8
Pancreatitis	7	7
Septic Shock	7	7
Unspecified Hepatic or Biliary Problem	6	6
Bruise/Contusion	6	6
Tachycardia	5	5
Granuloma	5	5
Low Blood Pressure/ Hypotension	5	5
Blood Loss	5	5
Drug Resistant Bacterial Infection	4	4
No Code Available	4	4
Tissue Damage	4	4
Erosion	4	4
Pneumonia	4	4
Discomfort	4	4
Viral Infection	4	4
Ulcer	3	3
Hypoxia	3	3
Hepatitis	3	3
Burn(s)	3	3
Peritonitis	3	3
Chemical Exposure	3	3
Rupture	3	3
Abdominal Distention	3	3
Inflammation	3	3
Intra-Abdominal Hemorrhage	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Aizu Olympus Co., Ltd.	II	Nov-29-2023
2	Aizu Olympus Co., Ltd.	II	Nov-17-2023
3	Olympus Corporation of the Americas	II	Oct-11-2024
4	Olympus Corporation of the Americas	II	Feb-29-2024
5	Olympus Corporation of the Americas	II	Nov-09-2023
6	Olympus Corporation of the Americas	II	Jun-21-2022
7	Olympus Corporation of the Americas	II	Nov-27-2020
8	Pentax of America Inc	II	Sep-10-2021
9	Pentax of America Inc	II	Feb-19-2020