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
SONOSCAPE MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Peeled/Delaminated	1934	1934
Material Split, Cut or Torn	1589	1589
Detachment of Device or Device Component	1553	1553
Failure to Clean Adequately	1045	1045
Break	1041	1041
Crack	729	729
Material Separation	672	672
Microbial Contamination of Device	659	659
No Display/Image	587	587
Fluid/Blood Leak	578	578
Obstruction of Flow	477	477
Device Reprocessing Problem	354	354
Degraded	268	268
Component Missing	258	258
Scratched Material	225	225
Material Puncture/Hole	223	223
Erratic or Intermittent Display	220	220
Contamination	213	213
Optical Obstruction	188	188
Adverse Event Without Identified Device or Use Problem	181	182
Poor Quality Image	150	150
Loss of or Failure to Bond	117	117
Material Integrity Problem	110	110
Material Fragmentation	107	107
Material Deformation	105	105
Mechanical Problem	90	90
Contamination /Decontamination Problem	86	86
Corroded	83	83
Leak/Splash	72	72
Dent in Material	69	69
Device Contamination with Chemical or Other Material	68	68
Loose or Intermittent Connection	64	64
Separation Problem	64	64
Unintended Movement	62	62
Residue After Decontamination	61	61
Optical Distortion	54	54
Defective Component	39	39
Gas/Air Leak	35	35
Material Discolored	30	30
Partial Blockage	29	29
Display or Visual Feedback Problem	28	28
Physical Resistance/Sticking	28	28
Device Contaminated at the User Facility	21	21
Communication or Transmission Problem	20	20
Mechanical Jam	20	20
Pitted	20	20
Complete Blockage	19	19
Fracture	19	19
Defective Device	18	18
Failure to Align	16	16

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11370	11370
Insufficient Information	105	105
Hemorrhage/Bleeding	85	85
No Patient Involvement	79	79
No Consequences Or Impact To Patient	70	70
Pancreatitis	41	41
Perforation	31	31
Peritonitis	27	27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	23	23
Unspecified Infection	23	23
Unspecified Hepatic or Biliary Problem	23	23
Sepsis	21	21
Bacterial Infection	16	16
Abdominal Pain	15	15
Pain	10	10
Abscess	10	10
Fever	10	10
Gastrointestinal Hemorrhage	9	9
Septic Shock	8	8
Internal Organ Perforation	8	9
Unspecified Tissue Injury	7	7
Foreign Body In Patient	6	6
Thrombocytopenia	6	6
Bowel Perforation	6	6
Unspecified Gastrointestinal Problem	6	6
Obstruction/Occlusion	4	4
Respiratory Failure	4	4
Biliary Cirrhosis	4	4
Aspiration Pneumonitis	4	4
Laceration(s) of Esophagus	3	3
Inflammation	3	3
Hematoma	3	3
Pseudoaneurysm	3	3
Fungal Infection	3	3
Failure of Implant	3	3
Pulmonary Embolism	3	3
Laceration(s)	3	3
Ulcer	2	2
Hypoxia	2	2
Bradycardia	2	2
Fistula	2	2
Chest Pain	2	2
Retroperitoneal Hemorrhage	2	2
Thrombosis/Thrombus	2	2
Pulmonary Emphysema	2	2
Aspiration/Inhalation	2	2
Apnea	2	2
Drug Resistant Bacterial Infection	2	2
Hematemesis	1	1
Peeling	1	1