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	3
PENTAX OF AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Clean Adequately	2844	2844
Detachment of Device or Device Component	1380	1380
Break	1199	1199
Microbial Contamination of Device	1057	1057
Device Reprocessing Problem	686	686
Contamination	621	621
Adverse Event Without Identified Device or Use Problem	562	562
Peeled/Delaminated	398	398
Device Contamination with Chemical or Other Material	338	338
Mechanical Problem	290	290
Fluid/Blood Leak	261	261
Contamination /Decontamination Problem	256	256
Crack	248	248
Optical Obstruction	226	226
Material Separation	216	216
Optical Problem	196	196
Use of Device Problem	179	179
Obstruction of Flow	158	158
Material Split, Cut or Torn	137	137
Material Discolored	125	125
Mechanical Jam	117	117
Loss of or Failure to Bond	110	110
Poor Quality Image	91	91
Corroded	90	90
Separation Problem	87	87
Device Fell	81	81
Leak/Splash	69	69
Insufficient Information	64	64
Erratic or Intermittent Display	62	62
No Display/Image	55	55
Residue After Decontamination	39	39
Optical Discoloration	38	38
Material Puncture/Hole	38	38
Physical Resistance/Sticking	37	37
Burst Container or Vessel	35	35
Material Frayed	32	32
Material Too Rigid or Stiff	28	28
Degraded	28	28
Optical Distortion	28	28
Component Missing	28	28
Material Deformation	28	28
Partial Blockage	27	27
Defective Component	27	27
Difficult to Advance	27	27
Unintended Movement	25	25
Material Twisted/Bent	25	25
Device Dislodged or Dislocated	24	24
Difficult to Remove	22	22
Complete Blockage	22	22
Improper or Incorrect Procedure or Method	20	20

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9411	9411
No Consequences Or Impact To Patient	505	505
Foreign Body In Patient	278	278
Hemorrhage/Bleeding	228	228
Pancreatitis	226	226
Unspecified Tissue Injury	184	184
Bacterial Infection	154	154
Perforation	145	145
No Known Impact Or Consequence To Patient	139	139
Unspecified Infection	101	101
Laceration(s)	101	101
No Patient Involvement	99	99
Insufficient Information	88	88
Unspecified Hepatic or Biliary Problem	85	85
Device Embedded In Tissue or Plaque	57	57
Sepsis	47	47
Abdominal Pain	37	37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	34	34
Laceration(s) of Esophagus	26	26
Internal Organ Perforation	24	24
Perforation of Esophagus	24	24
Fever	24	24
Bowel Burn	20	20
Abscess	19	19
Airway Obstruction	18	18
Vomiting	18	18
Pneumonia	16	16
Inflammation	16	16
Drug Resistant Bacterial Infection	15	15
Cough	15	15
Bowel Perforation	14	14
Gastrointestinal Hemorrhage	13	13
Tissue Breakdown	12	12
Pain	12	12
Septic Shock	11	11
Injury	10	10
Blood Loss	10	10
Tissue Damage	9	9
Death	9	9
No Code Available	9	9
Obstruction/Occlusion	8	8
Nausea	8	8
Abrasion	7	7
Fistula	7	7
Cardiac Arrest	7	7
Fungal Infection	7	7
Low Blood Pressure/ Hypotension	6	6
Aspiration Pneumonitis	5	5
Peritonitis	5	5
Low Oxygen Saturation	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