TPLC - Total Product Life Cycle

• Device: speculum, vaginal, nonmetal
• Product Code: HIB
• Regulation Number: 884.4530
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CLEARSPEC LLC
	SUBSTANTIALLY EQUIVALENT	1
IOB MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
KOLPLAST CI LTDA
	SUBSTANTIALLY EQUIVALENT	1
KUNSHAN DEYI PLASTIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OBP CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PROA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	8	8
2015	5	5
2016	1	1
2017	5	5
2018	3	3
2019	4	4
2020	4	4
2021	4	4
2022	2	2
2023	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	20	20
Shipping Damage or Problem	8	8
Fracture	6	6
Crack	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Separation	2	2
Physical Property Issue	1	1
No Apparent Adverse Event	1	1
Electrical /Electronic Property Problem	1	1
Detachment Of Device Component	1	1
Peeled/Delaminated	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Laceration(s)	11	11
Vaginal Mucosa Damage	9	9
No Known Impact Or Consequence To Patient	6	6
No Clinical Signs, Symptoms or Conditions	5	5
No Consequences Or Impact To Patient	3	3
Burn, Thermal	2	2
Abrasion	2	2
No Code Available	2	2
Insufficient Information	2	2
Device Embedded In Tissue or Plaque	1	1
No Information	1	1
Corneal Abrasion	1	1
Pain	1	1
Foreign Body In Patient	1	1
Patient Problem/Medical Problem	1	1
Discomfort	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	CooperSurgical, Inc.	II	Jun-22-2015
2	Welch Allyn Inc	II	Oct-30-2015