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
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ONEPASS MEDICAL , 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	1523	1523
Break	1007	1007
Material Split, Cut or Torn	943	943
Failure to Clean Adequately	914	914
Microbial Contamination of Device	718	718
Detachment of Device or Device Component	712	712
Fluid/Blood Leak	617	617
Material Separation	531	531
Crack	487	487
No Display/Image	484	484
Obstruction of Flow	461	461
Device Reprocessing Problem	347	347
Component Missing	225	225
Erratic or Intermittent Display	215	215
Contamination	206	206
Adverse Event Without Identified Device or Use Problem	185	186
Optical Obstruction	182	182
Scratched Material	178	178
Material Puncture/Hole	160	160
Poor Quality Image	150	150
Degraded	131	131
Mechanical Problem	94	94
Contamination /Decontamination Problem	84	84
Device Contamination with Chemical or Other Material	80	80
Leak/Splash	79	79
Material Integrity Problem	76	76
Loss of or Failure to Bond	65	65
Separation Problem	64	64
Material Deformation	64	64
Loose or Intermittent Connection	63	63
Unintended Movement	62	62
Optical Distortion	54	54
Material Fragmentation	44	44
Residue After Decontamination	40	40
Defective Component	39	39
Dent in Material	37	37
Corroded	36	36
Display or Visual Feedback Problem	31	31
Partial Blockage	29	29
Material Discolored	28	28
Gas/Air Leak	26	26
Physical Resistance/Sticking	26	26
Failure to Align	21	21
Fracture	20	20
Defective Device	20	20
Device Contaminated at the User Facility	20	20
Pitted	19	19
Complete Blockage	16	16
Material Perforation	15	15
Output Problem	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	9055	9055
No Consequences Or Impact To Patient	273	273
No Patient Involvement	242	242
Insufficient Information	94	94
Hemorrhage/Bleeding	85	85
No Known Impact Or Consequence To Patient	62	62
Pancreatitis	40	40
Perforation	34	34
Peritonitis	27	27
Unspecified Infection	24	24
Unspecified Hepatic or Biliary Problem	23	23
Sepsis	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Bacterial Infection	16	16
Abdominal Pain	15	15
Abscess	10	10
Pain	10	10
Fever	10	10
Internal Organ Perforation	8	9
Gastrointestinal Hemorrhage	8	8
Septic Shock	8	8
Unspecified Tissue Injury	7	7
Unspecified Gastrointestinal Problem	6	6
Thrombocytopenia	6	6
Bowel Perforation	6	6
Foreign Body In Patient	6	6
Laceration(s) of Esophagus	5	5
Aspiration Pneumonitis	4	4
Respiratory Failure	4	4
Biliary Cirrhosis	4	4
Obstruction/Occlusion	4	4
Inflammation	3	3
Laceration(s)	3	3
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
Pulmonary Emphysema	2	2
Bradycardia	2	2
Aspiration/Inhalation	2	2
Hypoxia	2	2
Ulcer	2	2
Apnea	2	2
Drug Resistant Bacterial Infection	2	2
Fistula	2	2
Atrial Fibrillation	1	1

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