TPLC - Total Product Life Cycle

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Device	endoscopic ultrasound system, gastroenterology-urology
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	4
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	1213	1213
Break	821	821
Failure to Clean Adequately	627	627
Microbial Contamination of Device	618	618
Fluid/Blood Leak	562	562
Material Split, Cut or Torn	426	426
Material Separation	411	411
Obstruction of Flow	368	368
No Display/Image	273	273
Device Reprocessing Problem	239	239
Crack	237	237
Detachment of Device or Device Component	178	178
Contamination	177	177
Erratic or Intermittent Display	162	162
Adverse Event Without Identified Device or Use Problem	158	158
Optical Obstruction	138	138
Component Missing	123	123
Material Puncture/Hole	102	102
Scratched Material	96	96
Mechanical Problem	86	86
Device Contamination with Chemical or Other Material	79	79
Contamination /Decontamination Problem	72	72
Leak/Splash	67	67
Poor Quality Image	64	64
Unintended Movement	58	58
Optical Distortion	53	53
Separation Problem	50	50
Loose or Intermittent Connection	40	40
Defective Component	35	35
Material Integrity Problem	34	34
Material Deformation	34	34
Partial Blockage	28	28
Dent in Material	23	23
Loss of or Failure to Bond	22	22
Failure to Align	21	21
Display or Visual Feedback Problem	21	21
Degraded	18	18
Defective Device	18	18
Physical Resistance/Sticking	16	16
Material Fragmentation	15	15
Pitted	15	15
Output Problem	14	14
Material Perforation	14	14
Fracture	13	13
Failure to Disconnect	13	13
Complete Blockage	12	12
Use of Device Problem	12	12
Material Discolored	12	12
Device Contamination with Body Fluid	12	12
Deformation Due to Compressive Stress	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6188	6188
No Consequences Or Impact To Patient	285	285
No Patient Involvement	248	248
No Known Impact Or Consequence To Patient	122	122
Insufficient Information	72	72
Hemorrhage/Bleeding	67	67
Perforation	39	39
Pancreatitis	34	34
Unspecified Hepatic or Biliary Problem	21	21
Peritonitis	21	21
Sepsis	19	19
Bacterial Infection	17	17
Unspecified Infection	11	11
Pain	10	10
Abdominal Pain	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Injury	9	9
Fever	9	9
Internal Organ Perforation	8	8
Unspecified Tissue Injury	7	7
Septic Shock	7	7
Thrombocytopenia	6	6
Foreign Body In Patient	6	6
Abscess	6	6
Unspecified Gastrointestinal Problem	6	6
Inflammation	5	5
Obstruction/Occlusion	4	4
Aspiration Pneumonitis	4	4
Respiratory Failure	4	4
Laceration(s) of Esophagus	4	4
Gastrointestinal Hemorrhage	4	4
Biliary Cirrhosis	4	4
Bowel Perforation	4	4
Pulmonary Embolism	3	3
Failure of Implant	3	3
Pseudoaneurysm	3	3
Aspiration/Inhalation	2	2
Laceration(s)	2	2
Chest Pain	2	2
Bradycardia	2	2
Retroperitoneal Hemorrhage	2	2
Shock	2	2
Thrombosis/Thrombus	2	2
Hypoxia	2	2
Ulcer	2	2
Pulmonary Emphysema	2	2
Death	2	2
Apnea	2	2
Fistula	2	2
Perforation of Esophagus	1	1

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