TPLC - Total Product Life Cycle

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Device	endoscopic grasping/cutting instrument, non-powered
Definition	To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Product Code	OCZ
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ENDOCHOICE, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SLATER ENDOSCOPY, LLC
	SUBSTANTIALLY EQUIVALENT	2
UNITED STATES ENDOSCOPY GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	2
USGI MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Operates Differently Than Expected	672	672
Device Packaging Compromised	572	572
Break	522	522
Crack	183	183
Material Integrity Problem	78	78
Peeled/Delaminated	72	72
Difficult to Open or Close	20	20
Mechanics Altered	18	18
Adverse Event Without Identified Device or Use Problem	15	15
Detachment of Device or Device Component	14	14
Material Separation	13	13
Material Fragmentation	11	11
Physical Property Issue	9	9
Component Missing	8	8
Arcing	8	8
Device Inoperable	7	7
Difficult to Remove	6	6
Detachment Of Device Component	6	6
Insufficient Information	5	5
Thermal Decomposition of Device	5	5
Mechanical Problem	5	5
Activation, Positioning or Separation Problem	4	4
Entrapment of Device	4	4
Bent	3	3
Failure of Device to Self-Test	3	3
Flushing Problem	3	3
Component Falling	3	3
Temperature Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Material Twisted/Bent	3	3
Defective Component	3	3
Mechanical Jam	2	2
Hole In Material	2	2
Loose or Intermittent Connection	2	2
Physical Resistance/Sticking	2	2
Failure to Cut	2	2
Product Quality Problem	2	2
Defective Device	2	2
Appropriate Term/Code Not Available	2	2
Device Fell	2	2
Unintended Movement	2	2
Failure to Align	1	1
Failure to Power Up	1	1
Activation Problem	1	1
Migration or Expulsion of Device	1	1
Scratched Material	1	1
Material Discolored	1	1
Unsealed Device Packaging	1	1
Positioning Problem	1	1
Battery Problem: Low Impedance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	1876	1876
No Patient Involvement	62	62
No Clinical Signs, Symptoms or Conditions	60	60
No Information	36	36
No Consequences Or Impact To Patient	26	26
Insufficient Information	22	22
Foreign Body In Patient	16	16
No Code Available	7	7
Superficial (First Degree) Burn	4	4
Burn(s)	4	4
Laceration(s)	4	4
Hemorrhage/Bleeding	4	4
Device Embedded In Tissue or Plaque	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Abdominal Distention	2	2
Perforation	2	2
Patient Problem/Medical Problem	1	1
Abdominal Pain	1	1
Death	1	1
Bowel Perforation	1	1
Blister	1	1
Pericardial Effusion	1	1
Unspecified Kidney or Urinary Problem	1	1
Pain	1	1
Tissue Damage	1	1
Partial thickness (Second Degree) Burn	1	1
Granuloma	1	1
Low Blood Pressure/ Hypotension	1	1