TPLC - Total Product Life Cycle

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Device	duodenoscope and accessories, flexible/rigid
Regulation Description	Endoscope and accessories.
Definition	To examine the duodenum and to perform various procedures within the duodenum. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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	FDT
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	1
AMBU INNOVATION GMBH
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	4
PENTAX OF AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Clean Adequately	3216	3216
Detachment of Device or Device Component	1484	1484
Break	1248	1248
Microbial Contamination of Device	1217	1217
Device Reprocessing Problem	865	865
Peeled/Delaminated	661	661
Contamination	642	642
Adverse Event Without Identified Device or Use Problem	584	584
Crack	532	532
Device Contamination with Chemical or Other Material	338	338
Mechanical Problem	292	292
Fluid/Blood Leak	265	265
Contamination /Decontamination Problem	261	261
Material Separation	239	239
Optical Obstruction	236	236
Optical Problem	224	224
Material Split, Cut or Torn	180	180
Use of Device Problem	179	179
Obstruction of Flow	174	174
Material Discolored	169	169
Residue After Decontamination	146	146
Corroded	142	142
Mechanical Jam	126	126
Loss of or Failure to Bond	115	115
Poor Quality Image	100	100
Flare or Flash	91	91
Degraded	91	91
Separation Problem	89	89
Device Fell	84	84
Leak/Splash	72	72
Erratic or Intermittent Display	69	69
Thermal Decomposition of Device	68	68
No Display/Image	68	70
Insufficient Information	68	68
Melted	67	67
Material Deformation	63	63
Material Fragmentation	52	52
Material Puncture/Hole	49	49
Scratched Material	46	46
Optical Discoloration	42	42
Physical Resistance/Sticking	41	41
Burst Container or Vessel	36	36
Positioning Failure	32	32
Material Frayed	32	32
Difficult to Remove	31	31
Component Missing	30	30
Difficult to Advance	30	30
Partial Blockage	29	29
Optical Distortion	28	28
Material Too Rigid or Stiff	28	28

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11282	11282
No Consequences Or Impact To Patient	505	505
Foreign Body In Patient	289	289
Pancreatitis	237	237
Hemorrhage/Bleeding	231	231
Unspecified Tissue Injury	184	184
Bacterial Infection	159	159
Perforation	147	147
No Known Impact Or Consequence To Patient	139	141
Insufficient Information	104	104
Laceration(s)	103	103
Unspecified Infection	102	102
No Patient Involvement	99	99
Unspecified Hepatic or Biliary Problem	90	90
Device Embedded In Tissue or Plaque	57	57
Sepsis	47	47
Abdominal Pain	38	38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	38	38
Laceration(s) of Esophagus	26	26
Perforation of Esophagus	26	26
Abscess	25	25
Internal Organ Perforation	24	24
Fever	24	24
Bowel Perforation	21	21
Bowel Burn	20	20
Vomiting	19	19
Airway Obstruction	18	18
Pneumonia	16	16
Gastrointestinal Hemorrhage	16	16
Inflammation	16	16
Septic Shock	15	15
Drug Resistant Bacterial Infection	15	15
Cough	15	15
Pain	13	13
Tissue Breakdown	12	12
Obstruction/Occlusion	10	10
Blood Loss	10	10
Injury	10	10
Tissue Damage	9	9
No Code Available	9	9
Death	9	9
Peritonitis	8	8
Nausea	8	8
Abrasion	7	7
Fungal Infection	7	7
Cardiac Arrest	7	7
Fistula	7	7
Low Blood Pressure/ Hypotension	6	6
Hematoma	5	5
Pulmonary Edema	5	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Nov-21-2023
2	Boston Scientific Corporation	II	May-13-2022
3	Boston Scientific Corporation	III	Apr-26-2021
4	Olympus Corporation of the Americas	II	Feb-09-2024
5	Olympus Corporation of the Americas	II	Aug-28-2023
6	Olympus Corporation of the Americas	II	May-19-2023
7	Olympus Corporation of the Americas	II	Dec-10-2021
8	Olympus Corporation of the Americas	II	Mar-22-2021
9	Pentax of America Inc	II	May-25-2021