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	2075	2075
Detachment of Device or Device Component	1875	1875
Material Split, Cut or Torn	1779	1779
Break	1157	1157
Failure to Clean Adequately	1123	1123
Crack	910	910
Material Separation	706	706
Microbial Contamination of Device	692	692
No Display/Image	647	647
Fluid/Blood Leak	589	589
Obstruction of Flow	480	480
Degraded	404	404
Device Reprocessing Problem	399	399
Material Puncture/Hole	268	268
Component Missing	265	265
Scratched Material	264	264
Erratic or Intermittent Display	226	226
Contamination	222	222
Optical Obstruction	190	190
Adverse Event Without Identified Device or Use Problem	181	182
Material Deformation	168	168
Material Fragmentation	164	164
Poor Quality Image	162	162
Corroded	161	162
Residue After Decontamination	135	135
Loss of or Failure to Bond	134	134
Material Integrity Problem	126	126
Contamination /Decontamination Problem	91	91
Mechanical Problem	91	91
Dent in Material	76	76
Leak/Splash	72	72
Device Contamination with Chemical or Other Material	68	68
Loose or Intermittent Connection	65	65
Separation Problem	65	65
Unintended Movement	62	62
Optical Distortion	55	55
Defective Component	39	39
Gas/Air Leak	38	38
Material Discolored	37	37
Physical Resistance/Sticking	34	34
Fracture	31	31
Display or Visual Feedback Problem	30	30
Partial Blockage	29	29
Mechanical Jam	23	23
Communication or Transmission Problem	23	23
Pitted	21	21
Device Contaminated at the User Facility	21	21
Complete Blockage	20	20
Defective Device	18	18
Output Problem	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	12598	12599
Insufficient Information	109	109
Hemorrhage/Bleeding	85	85
No Patient Involvement	79	79
No Consequences Or Impact To Patient	70	70
Pancreatitis	43	43
Perforation	33	33
Peritonitis	27	27
Unspecified Infection	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	23	23
Unspecified Hepatic or Biliary Problem	23	23
Sepsis	21	21
Bacterial Infection	16	16
Abdominal Pain	15	15
Abscess	10	10
Pain	10	10
Fever	10	10
Gastrointestinal Hemorrhage	9	9
Septic Shock	8	8
Internal Organ Perforation	8	9
Unspecified Tissue Injury	7	7
Thrombocytopenia	6	6
Unspecified Gastrointestinal Problem	6	6
Bowel Perforation	6	6
Foreign Body In Patient	6	6
Biliary Cirrhosis	4	4
Respiratory Failure	4	4
Obstruction/Occlusion	4	4
Aspiration Pneumonitis	4	4
Multiple Organ Failure	3	3
Laceration(s) of Esophagus	3	3
Pulmonary Embolism	3	3
Inflammation	3	3
Laceration(s)	3	3
Hematoma	3	3
Fungal Infection	3	3
Failure of Implant	3	3
Pseudoaneurysm	3	3
Thrombosis/Thrombus	2	2
Retroperitoneal Hemorrhage	2	2
Chest Pain	2	2
Pulmonary Emphysema	2	2
Aspiration/Inhalation	2	2
Bradycardia	2	2
Fistula	2	2
Drug Resistant Bacterial Infection	2	2
Apnea	2	2
Hypoxia	2	2
Ulcer	2	2
Low Blood Pressure/ Hypotension	1	1