TPLC - Total Product Life Cycle

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Device	endoscopic ultrasound system, gastroenterology-urology
Regulation Description	Endoscope and accessories.
Definition	To provide ultrasonic visualization of body cavities that can be accessed by endoscope. 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	ODG
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ENDOSOUND, INC
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
MICRO-TECH(NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PENTAX OF AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
SONOSCAPE MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Peeled/Delaminated	1264	1264
Break	866	866
Failure to Clean Adequately	773	773
Microbial Contamination of Device	647	647
Fluid/Blood Leak	600	600
Material Split, Cut or Torn	479	479
Material Separation	472	472
Obstruction of Flow	443	443
No Display/Image	357	357
Device Reprocessing Problem	305	305
Crack	275	275
Detachment of Device or Device Component	214	214
Erratic or Intermittent Display	204	204
Contamination	195	195
Optical Obstruction	173	173
Adverse Event Without Identified Device or Use Problem	166	166
Component Missing	130	130
Material Puncture/Hole	113	113
Scratched Material	111	111
Mechanical Problem	89	89
Poor Quality Image	81	81
Device Contamination with Chemical or Other Material	79	79
Contamination /Decontamination Problem	78	78
Leak/Splash	78	78
Separation Problem	63	63
Unintended Movement	60	60
Optical Distortion	53	53
Loose or Intermittent Connection	50	50
Material Deformation	40	40
Defective Component	38	38
Material Integrity Problem	37	37
Partial Blockage	29	29
Loss of or Failure to Bond	27	27
Dent in Material	24	24
Display or Visual Feedback Problem	23	23
Physical Resistance/Sticking	21	21
Failure to Align	21	21
Degraded	20	20
Material Fragmentation	18	18
Material Discolored	17	17
Defective Device	17	17
Pitted	16	16
Output Problem	15	15
Material Perforation	15	15
Device Contamination with Body Fluid	14	14
Complete Blockage	14	14
Fracture	14	14
Failure to Disconnect	13	13
Use of Device Problem	12	12
Corroded	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7119	7119
No Consequences Or Impact To Patient	273	273
No Patient Involvement	242	242
Insufficient Information	78	78
Hemorrhage/Bleeding	77	77
No Known Impact Or Consequence To Patient	62	62
Pancreatitis	37	37
Perforation	33	33
Peritonitis	25	25
Unspecified Infection	23	23
Unspecified Hepatic or Biliary Problem	23	23
Sepsis	21	21
Bacterial Infection	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Abdominal Pain	13	13
Abscess	10	10
Pain	10	10
Fever	9	9
Internal Organ Perforation	8	8
Gastrointestinal Hemorrhage	7	7
Unspecified Tissue Injury	7	7
Septic Shock	7	7
Unspecified Gastrointestinal Problem	6	6
Thrombocytopenia	6	6
Foreign Body In Patient	6	6
Aspiration Pneumonitis	4	4
Respiratory Failure	4	4
Biliary Cirrhosis	4	4
Obstruction/Occlusion	4	4
Laceration(s) of Esophagus	4	4
Bowel Perforation	4	4
Hematoma	3	3
Pseudoaneurysm	3	3
Fungal Infection	3	3
Failure of Implant	3	3
Pulmonary Embolism	3	3
Thrombosis/Thrombus	2	2
Retroperitoneal Hemorrhage	2	2
Chest Pain	2	2
Laceration(s)	2	2
Pulmonary Emphysema	2	2
Bradycardia	2	2
Aspiration/Inhalation	2	2
Hypoxia	2	2
Ulcer	2	2
Fistula	2	2
Apnea	2	2
Multiple Organ Failure	1	1
Rupture	1	1
Atrial Fibrillation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Olympus Corporation of the Americas	II	Nov-27-2020