TPLC - Total Product Life Cycle

show TPLC since

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	44	44
Difficult to Open or Close	22	22
Adverse Event Without Identified Device or Use Problem	14	14
Material Fragmentation	10	10
Material Separation	9	9
Detachment of Device or Device Component	9	9
Insufficient Information	6	6
Mechanical Problem	4	4
Difficult to Remove	4	4
Arcing	4	4
Material Twisted/Bent	3	3
Mechanics Altered	3	3
Flushing Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Mechanical Jam	3	3
Temperature Problem	3	3
Activation, Positioning or Separation Problem	2	2
Entrapment of Device	2	2
Physical Resistance/Sticking	2	2
Unintended Movement	2	2
Defective Device	2	2
Use of Device Problem	2	2
Failure to Cut	2	2
Unexpected Shutdown	1	1
Activation Problem	1	1
Device Fell	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Device Damaged by Another Device	1	1
Sharp Edges	1	1
Material Deformation	1	1
Packaging Problem	1	1
Product Quality Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Activation Failure	1	1
Device Reprocessing Problem	1	1
Connection Problem	1	1
Arcing of Electrodes	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	77	77
Insufficient Information	28	28
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Perforation	2	2
Abdominal Pain	1	1
Patient Problem/Medical Problem	1	1
Death	1	1
Bowel Perforation	1	1
Abdominal Distention	1	1
Pericardial Effusion	1	1
Blister	1	1
No Patient Involvement	1	1
Pain	1	1
Unspecified Kidney or Urinary Problem	1	1
Tissue Damage	1	1
Partial thickness (Second Degree) Burn	1	1
Granuloma	1	1
Low Blood Pressure/ Hypotension	1	1
Device Embedded In Tissue or Plaque	1	1