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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
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
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 2
SUZHOU ACUVU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 193 195
2022 289 291
2023 1449 1449
2024 1611 1613
2025 1713 1713

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2887 2889
Detachment of Device or Device Component 751 751
Adverse Event Without Identified Device or Use Problem 373 373
Crack 184 184
Material Fragmentation 138 138
Loose or Intermittent Connection 95 95
Mechanical Problem 92 92
Component Missing 78 78
Material Integrity Problem 77 77
Fracture 63 63
Material Protrusion/Extrusion 61 61
Material Deformation 59 59
Material Separation 54 54
Poor Quality Image 50 50
Use of Device Problem 44 44
Insufficient Information 41 42
Scratched Material 37 37
Mechanical Jam 31 32
Material Twisted/Bent 29 29
Fail-Safe Problem 28 28
Defective Component 26 26
Unexpected Shutdown 25 25
Appropriate Term/Code Not Available 25 25
Material Split, Cut or Torn 23 23
Loss of or Failure to Bond 22 22
Intermittent Energy Output 22 22
Device Reprocessing Problem 22 22
Failure to Clean Adequately 21 21
Material Disintegration 20 21
Unstable 19 19
Dent in Material 18 18
No Display/Image 18 18
Microbial Contamination of Device 17 17
Sharp Edges 17 17
Degraded 16 16
Optical Problem 15 15
Material Opacification 14 14
Failure to Cut 14 14
Sparking 14 14
Defective Device 14 14
Peeled/Delaminated 13 13
Thermal Decomposition of Device 13 13
Suction Problem 13 13
Device Displays Incorrect Message 12 12
Output Problem 12 12
Corroded 12 12
Melted 12 12
Contamination 11 11
Energy Output Problem 11 11
Unintended Movement 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4518 4519
Insufficient Information 213 215
Foreign Body In Patient 197 198
Uterine Perforation 156 156
Hemorrhage/Bleeding 48 48
Bowel Perforation 44 44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Burn(s) 16 17
Bacterial Infection 12 12
Laceration(s) 11 11
Perforation 11 11
Unspecified Tissue Injury 10 10
Electric Shock 8 8
Internal Organ Perforation 8 9
No Consequences Or Impact To Patient 8 8
Adhesion(s) 8 8
Pain 7 8
Convulsion/Seizure 6 6
Urethral Stenosis/Stricture 5 5
Intermenstrual Bleeding 5 5
Bowel Burn 5 5
Sepsis 5 5
Tissue Breakdown 5 5
Abdominal Pain 5 5
Pulmonary Edema 4 4
Hematoma 4 4
Unspecified Kidney or Urinary Problem 4 4
Superficial (First Degree) Burn 4 4
Unspecified Infection 4 4
Discomfort 4 4
Hypervolemia 3 3
Rupture 3 3
Incomplete Induced Abortion 3 3
Vaginal Mucosa Damage 3 3
Air Embolism 3 3
Fever 3 3
Muscle/Tendon Damage 2 2
Bradycardia 2 2
Cancer 2 2
Unintended Radiation Exposure 2 2
Ecchymosis 2 2
Urinary Retention 2 2
Cancer Cells Dissemination 2 2
Fallopian Tube Perforation 2 2
Cardiac Arrest 2 2
Easy Bruising 2 2
Atrial Fibrillation 2 2
Anemia 2 2
Abdominal Distention 2 2
Unspecified Gastrointestinal Problem 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 Jul-21-2025
4 Olympus Corporation of the Americas II Jun-06-2024
5 Olympus Corporation of the Americas II Aug-29-2023
6 Scholly Fiberoptic Gmbh II Aug-09-2023
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