TPLC - Total Product Life Cycle

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Device	hysteroscope (and accessories)
Regulation Description	Hysteroscope and accessories.
Product Code	HIH
Regulation Number	884.1690
Device Class	2

Premarket Reviews
Manufacturer	Decision
ACUVU INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CALDERA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
COOPERSURGICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
HYSTEROVUE, INC.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU JIYUAN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ ENDOSCOPY AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ-ENDOSCOPY-AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
LINA MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDITRINA, INC.
	SUBSTANTIALLY EQUIVALENT	2
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS WINTER & IBE GMBH
	SUBSTANTIALLY EQUIVALENT	1
ORIGYN MEDICAL TECHNOLOGY (HANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SCHOELLY FIBEROPTIC GMBH
	SUBSTANTIALLY EQUIVALENT	1
STRYKER ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SUSTAINABILITY SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU ACUVU MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	2225	2225
Detachment of Device or Device Component	454	454
Adverse Event Without Identified Device or Use Problem	352	352
Crack	132	132
Material Fragmentation	114	114
Mechanical Problem	74	74
Loose or Intermittent Connection	73	73
Component Missing	70	70
Material Integrity Problem	70	70
Material Separation	56	56
Poor Quality Image	55	55
Material Protrusion/Extrusion	46	46
Fracture	45	45
Insufficient Information	36	36
Material Deformation	34	34
Use of Device Problem	32	32
Scratched Material	31	31
Material Twisted/Bent	29	29
Defective Device	24	24
Mechanical Jam	23	23
Intermittent Energy Output	23	23
No Display/Image	22	22
Defective Component	21	21
Appropriate Term/Code Not Available	21	21
Microbial Contamination of Device	20	20
Fail-Safe Problem	17	17
Material Split, Cut or Torn	17	17
Failure to Cut	15	15
Suction Problem	15	15
Thermal Decomposition of Device	12	12
Device Reprocessing Problem	12	12
Sharp Edges	11	11
Failure to Clean Adequately	11	11
Device Fell	11	11
Material Disintegration	11	11
Melted	10	10
Optical Problem	10	10
Dent in Material	10	10
Connection Problem	9	9
Device Displays Incorrect Message	9	9
Material Puncture/Hole	8	8
Incorrect Measurement	8	8
Material Opacification	8	8
Device Misassembled During Manufacturing /Shipping	8	8
Energy Output Problem	7	7
Peeled/Delaminated	7	7
Fluid/Blood Leak	7	7
Dull, Blunt	7	7
Excessive Heating	6	6
Unintended Movement	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3236	3236
Foreign Body In Patient	169	169
Insufficient Information	163	163
Uterine Perforation	157	157
No Consequences Or Impact To Patient	78	78
No Patient Involvement	62	62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	41	41
Hemorrhage/Bleeding	41	41
Bowel Perforation	37	37
No Known Impact Or Consequence To Patient	20	20
Perforation	16	16
No Code Available	11	11
Burn(s)	10	10
Device Embedded In Tissue or Plaque	10	10
Unspecified Tissue Injury	10	10
Bacterial Infection	9	9
Internal Organ Perforation	8	8
Laceration(s)	8	8
Convulsion/Seizure	6	6
Electric Shock	6	6
Urethral Stenosis/Stricture	5	5
Pain	5	5
Sepsis	5	5
Unspecified Kidney or Urinary Problem	5	5
Patient Problem/Medical Problem	5	5
Superficial (First Degree) Burn	5	5
No Information	4	4
Adhesion(s)	4	4
Abdominal Distention	4	4
Discomfort	4	4
Unspecified Infection	4	4
Cancer	3	3
Death	3	3
Unintended Radiation Exposure	3	3
Rupture	3	3
Intermenstrual Bleeding	3	3
Incomplete Induced Abortion	3	3
Abdominal Pain	3	3
Vaginal Mucosa Damage	3	3
Ecchymosis	2	2
Pulmonary Edema	2	2
Bradycardia	2	2
Fever	2	2
Cancer Cells Dissemination	2	2
Muscle/Tendon Damage	2	2
Cardiac Arrest	2	2
Easy Bruising	2	2
Blood Loss	2	2
Burn, Thermal	2	2
Bowel Burn	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Aizu Olympus Co., Ltd.	II	Nov-17-2023
2	CooperSurgical, Inc.	II	May-22-2020
3	CooperSurgical, Inc.	II	Jan-10-2020
4	Covidien Llc	II	Jul-26-2022
5	Olympus Corporation of the Americas	II	Jun-06-2024
6	Olympus Corporation of the Americas	II	Aug-29-2023
7	Scholly Fiberoptic Gmbh	II	Aug-09-2023