TPLC - Total Product Life Cycle

• Device: microtools, assisted reproduction (pipettes)
• Product Code: MQH
• Regulation Number: 884.6130
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
JIEYING LABORATORY INC.
	SUBSTANTIALLY EQUIVALENT	1
LIFEGLOBAL GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
RESEARCH INSTRUMENTS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
RESEARCH INSTRUMENTS LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUNLIGHT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
VITROMED GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	1	1
2016	2	2
2017	1	1
2019	4	4
2021	10	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Nonstandard Device	4	4
Insufficient Information	3	3
Microbial Contamination of Device	3	3
Product Quality Problem	2	2
Material Rupture	1	1
Contamination	1	1
Crack	1	1
Material Fragmentation	1	1
Defective Device	1	1
Device Operates Differently Than Expected	1	1
Device Contamination with Chemical or Other Material	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	7	7
No Known Impact Or Consequence To Patient	6	6
No Clinical Signs, Symptoms or Conditions	2	2
Device Embedded In Tissue or Plaque	1	1
Insufficient Information	1	1
No Patient Involvement	1	1
Death	1	1
Bone Fracture(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CooperSurgical, Inc.	II	May-17-2019