TPLC - Total Product Life Cycle

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Device	endoscopic grasping/cutting instrument, non-powered
Regulation Description	Endoscope and accessories.
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
ENVISION ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	53	53
Difficult to Open or Close	22	22
Adverse Event Without Identified Device or Use Problem	14	14
Material Fragmentation	11	11
Detachment of Device or Device Component	9	9
Material Separation	9	9
Insufficient Information	7	7
Mechanical Problem	6	6
Difficult to Remove	4	4
Arcing	4	4
Material Twisted/Bent	3	3
Mechanical Jam	3	3
Mechanics Altered	3	3
Temperature Problem	3	3
Flushing Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Unintended Movement	2	2
Physical Resistance/Sticking	2	2
Entrapment of Device	2	2
Failure to Cut	2	2
Defective Device	2	2
Activation, Positioning or Separation Problem	2	2
Use of Device Problem	2	2
Unsealed Device Packaging	1	1
Product Quality Problem	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Packaging Problem	1	1
Activation Failure	1	1
Sharp Edges	1	1
Device Fell	1	1
Unexpected Shutdown	1	1
Activation Problem	1	1
Device Reprocessing Problem	1	1
Connection Problem	1	1
Device Damaged by Another Device	1	1
Electrical Overstress	1	1
Arcing of Electrodes	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	85	85
Insufficient Information	30	30
Foreign Body In Patient	15	15
No Code Available	5	5
No Consequences Or Impact To Patient	5	5
Superficial (First Degree) Burn	4	4
No Known Impact Or Consequence To Patient	4	4
Laceration(s)	4	4
Burn(s)	3	3
Hemorrhage/Bleeding	3	3
Perforation	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Abdominal Pain	1	1
Death	1	1
Granuloma	1	1
Low Blood Pressure/ Hypotension	1	1
Abdominal Distention	1	1
No Patient Involvement	1	1
Bowel Perforation	1	1
Patient Problem/Medical Problem	1	1
Partial thickness (Second Degree) Burn	1	1
Device Embedded In Tissue or Plaque	1	1
Pericardial Effusion	1	1
Unspecified Kidney or Urinary Problem	1	1
Pain	1	1
Tissue Damage	1	1
Blister	1	1