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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hysteroscope (and accessories)
Regulation Description Hysteroscope and accessories.
Product CodeHIH
Regulation Number 884.1690
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUVU, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL ENDOSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HYSTEROVUE, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU JIYUAN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ-ENDOSCOPY-AMERICA, INC.
  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
RZ MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU ACUVU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 193 195
2022 289 291
2023 1449 1449
2024 1611 1613
2025 1719 1719
2026 896 896

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3233 3235
Detachment of Device or Device Component 921 921
Adverse Event Without Identified Device or Use Problem 404 404
Crack 225 225
Material Fragmentation 176 176
Loose or Intermittent Connection 137 137
Mechanical Problem 97 97
Fracture 83 83
Material Integrity Problem 82 82
Component Missing 81 81
Material Deformation 70 70
Material Separation 66 66
Poor Quality Image 65 65
Material Protrusion/Extrusion 64 64
Use of Device Problem 51 51
Insufficient Information 48 49
Defective Component 47 47
Mechanical Jam 46 47
Scratched Material 43 43
Failure to Clean Adequately 42 42
Unstable 39 39
Corroded 38 38
Loss of or Failure to Bond 37 37
Degraded 32 32
Material Twisted/Bent 31 31
Peeled/Delaminated 30 30
Device Reprocessing Problem 28 28
Appropriate Term/Code Not Available 28 28
Fail-Safe Problem 28 28
Material Split, Cut or Torn 26 26
Unexpected Shutdown 25 25
Material Disintegration 24 25
Output Problem 23 23
Sharp Edges 23 23
Dent in Material 23 23
Intermittent Energy Output 22 22
No Display/Image 19 19
Energy Output Problem 19 19
Contamination 18 18
Optical Problem 18 18
Microbial Contamination of Device 17 17
Thermal Decomposition of Device 17 17
Sparking 17 17
Leak/Splash 17 17
Failure to Cut 16 16
Defective Device 16 16
Suction Problem 14 14
Material Opacification 14 14
Unintended Movement 13 13
Excessive Heating 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5346 5347
Insufficient Information 239 241
Foreign Body In Patient 215 216
Uterine Perforation 172 172
Hemorrhage/Bleeding 53 53
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 48 48
Bowel Perforation 44 44
Burn(s) 19 20
Perforation 13 13
Bacterial Infection 12 12
Unspecified Tissue Injury 11 11
Laceration(s) 11 11
Abdominal Pain 10 10
Tissue Breakdown 8 8
Internal Organ Perforation 8 9
No Consequences Or Impact To Patient 8 8
Electric Shock 8 8
Adhesion(s) 8 8
Pain 7 8
Convulsion/Seizure 6 6
Sepsis 6 6
Unspecified Infection 5 5
Superficial (First Degree) Burn 5 5
Dysuria 5 5
Hematoma 5 5
Bowel Burn 5 5
Intermenstrual Bleeding 5 5
Urethral Stenosis/Stricture 5 5
Pulmonary Edema 4 4
Unspecified Kidney or Urinary Problem 4 4
Discomfort 4 4
Fever 4 4
Hypervolemia 3 3
Bradycardia 3 3
Vaginal Mucosa Damage 3 3
Cardiac Arrest 3 3
Rupture 3 3
Incomplete Induced Abortion 3 3
Air Embolism 3 3
Easy Bruising 2 2
Fallopian Tube Perforation 2 2
Cancer Cells Dissemination 2 2
Atrial Fibrillation 2 2
Anemia 2 2
Abdominal Distention 2 2
Urinary Retention 2 2
Inflammation 2 2
Ecchymosis 2 2
Unspecified Gastrointestinal Problem 2 2
Muscle/Tendon Damage 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Covidien Llc II Jul-26-2022
3 Olympus Corporation of the Americas II Feb-20-2026
4 Olympus Corporation of the Americas II Jul-21-2025
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
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