TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
APOLLO ENDOSURGERY, INC.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING ZKSK TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
ENDO-THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENDOCHOICE, INC.
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM MEDICAL SYSTEM U.S.A., INC.
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
	SUBSTANTIALLY EQUIVALENT	2
HANGZHOU AGS MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
OVESCO ENDOSCOPY AG
	SUBSTANTIALLY EQUIVALENT	1
SLATER ENDOSCOPY, LLC
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
WILSON-COOK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Tear, Rip or Hole in Device Packaging	27	27
Adverse Event Without Identified Device or Use Problem	19	19
Failure to Align	13	13
Unintended Movement	10	10
Device Operates Differently Than Expected	9	9
Difficult to Open or Close	9	9
Break	9	9
Illegible Information	7	7
Device Contamination with Chemical or Other Material	6	6
Mechanical Jam	4	4
Failure to Deliver Energy	4	4
Mechanical Problem	4	4
Device Handling Problem	4	4
Failure to Cut	3	3
Dull, Blunt	3	3
Insufficient Heating	3	3
Material Separation	3	3
Material Twisted/Bent	3	3
Failure to Power Up	3	3
Use of Device Problem	3	3
Suction Failure	2	2
Overheating of Device	2	2
Detachment of Device or Device Component	2	2
No Apparent Adverse Event	2	2
Material Deformation	2	2
Bent	2	2
Material Fragmentation	2	2
Output Problem	2	2
Communication or Transmission Problem	2	2
Intermittent Loss of Power	2	2
Complete Loss of Power	2	2
Solder Joint Fracture	1	1
Packaging Problem	1	1
Off-Label Use	1	1
Material Frayed	1	1
Unexpected Shutdown	1	1
Device Contaminated During Manufacture or Shipping	1	1
Failure to Deliver Shock/Stimulation	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Loose or Intermittent Connection	1	1
Failure to Fire	1	1
Material Protrusion/Extrusion	1	1
Arcing	1	1
Fracture	1	1
Energy Output Problem	1	1
Separation Failure	1	1
Difficult to Advance	1	1
Therapeutic or Diagnostic Output Failure	1	1
Positioning Problem	1	1
Failure to Clean Adequately	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	49	49
No Clinical Signs, Symptoms or Conditions	38	38
No Patient Involvement	30	30
No Known Impact Or Consequence To Patient	12	12
Hemorrhage/Bleeding	9	9
Blood Loss	8	8
Perforation	7	7
No Information	4	4
Foreign Body In Patient	3	3
Insufficient Information	2	2
Pain	2	2
Tissue Damage	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Laceration(s) of Esophagus	1	1
Injury	1	1
Vomiting	1	1
Laceration(s)	1	1
Unspecified Tissue Injury	1	1
Bacterial Infection	1	1
Infiltration into Tissue	1	1