TPLC - Total Product Life Cycle

• Device: accessory, assisted reproduction
• Product Code: MQG
• Regulation Number: 884.6120
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AT MEDICAL UAB
	SUBSTANTIALLY EQUIVALENT	2
GENEA BIOMEDX PTY LTD
	SUBSTANTIALLY EQUIVALENT	3
ORIGIO, INC
	SUBSTANTIALLY EQUIVALENT	1
PLANER PLC
	SUBSTANTIALLY EQUIVALENT	1
RESEARCH INSTRUMENTS LIMITED
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI LISHEN SCIENTIFIC EQUIPMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
UNISENSE FERTILITECH A/S
	SUBSTANTIALLY EQUIVALENT	4
VITROLIFE A/S
	SUBSTANTIALLY EQUIVALENT	1
WILLIAM A. COOK AUSTRALIA PTY LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2016	1	1
2019	2	2
2020	3	3
2023	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Inappropriate/Inadequate Shock/Stimulation	2	2
Mechanical Problem	2	2
Off-Label Use	1	1
Sparking	1	1
Device Operates Differently Than Expected	1	1
Device Sensing Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Unintended Electrical Shock	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3	3
Electric Shock	2	2
No Known Impact Or Consequence To Patient	1	1
No Code Available	1	1
Hemorrhage/Bleeding	1	1
No Consequences Or Impact To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Inc.	II	Apr-19-2018
2	Cook Inc.	II	Apr-13-2018
3	Cook Medical Llc	II	Jan-12-2024
4	Cook Medical Llc	II	Jan-08-2021
5	CooperSurgical, Inc.	II	Sep-28-2022
6	CooperSurgical, Inc.	III	Oct-02-2019