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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)
Product CodeHIH
Regulation Number 884.1690
Device Class 2


Premarket Reviews
ManufacturerDecision
ACUVU INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
CORINTH MEDTECH, INC.
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
ENDOSEC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENDOSEE CORP
  SUBSTANTIALLY EQUIVALENT 1
FEMSUITE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GIMMI GMBH
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
HENKE-SASS, WOLF GMBH
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC
  SUBSTANTIALLY EQUIVALENT 3
HOLOGIC, INC.
  SUBSTANTIALLY EQUIVALENT 10
HYSTEROVUE, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERLACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERLACE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
IOGYN, 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 2
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDITRINA, INC.
  SUBSTANTIALLY EQUIVALENT 5
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NVISION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NVISION MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OBP MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
ORIGYN MEDICAL TECHNOLOGY (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
POLYGON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
REED MEDICAL (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SCHOELLY FIBEROPTIC GMBH
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU ACUVU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
UVISION360 INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 125 125
2015 211 211
2016 172 172
2017 336 336
2018 181 181
2019 220 220
2020 253 253
2021 193 193
2022 289 289
2023 1451 1451
2024 1104 1104

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2180 2180
Adverse Event Without Identified Device or Use Problem 535 535
Detachment of Device or Device Component 379 379
Material Fragmentation 132 132
Insufficient Information 126 126
Crack 106 106
Material Separation 106 106
Mechanical Problem 91 91
Device Operates Differently Than Expected 76 76
Component Missing 65 65
Material Integrity Problem 60 60
Loose or Intermittent Connection 58 58
Poor Quality Image 54 54
Detachment Of Device Component 47 47
Fracture 46 46
Material Protrusion/Extrusion 44 44
Material Opacification 37 37
Use of Device Problem 35 35
Mechanical Jam 35 35
Appropriate Term/Code Not Available 35 35
Material Deformation 31 31
Scratched Material 26 26
No Display/Image 26 26
Microbial Contamination of Device 25 25
Defective Device 25 25
Material Twisted/Bent 23 23
Suction Problem 22 22
Failure to Cut 22 22
Metal Shedding Debris 21 21
Defective Component 21 21
Mechanics Altered 19 19
Noise, Audible 18 18
Bent 17 17
Incorrect Measurement 17 17
Intermittent Energy Output 17 17
Material Split, Cut or Torn 16 16
Improper or Incorrect Procedure or Method 16 16
Fail-Safe Problem 13 13
Fluid/Blood Leak 13 13
Overheating of Device 13 13
Component Falling 12 12
Device Inoperable 12 12
Optical Problem 11 11
Unintended Movement 11 11
Device Fell 11 11
Device Reprocessing Problem 11 11
Leak/Splash 10 10
Device Slipped 10 10
Sharp Edges 10 10
Melted 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2543 2543
No Known Impact Or Consequence To Patient 414 415
No Consequences Or Impact To Patient 346 346
Uterine Perforation 252 252
Foreign Body In Patient 171 171
No Patient Involvement 146 146
Insufficient Information 127 127
Hemorrhage/Bleeding 92 92
Perforation 89 89
No Code Available 62 62
No Information 52 52
Bowel Perforation 52 52
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
Device Embedded In Tissue or Plaque 37 37
Blood Loss 26 26
Internal Organ Perforation 22 22
Tissue Damage 20 20
Injury 20 20
Pain 17 17
Hypervolemia 15 15
Death 13 13
Burn(s) 13 13
Complaint, Ill-Defined 11 11
Patient Problem/Medical Problem 11 11
Unspecified Infection 11 11
Air Embolism 11 11
Abdominal Distention 10 10
Bacterial Infection 9 9
Laceration(s) 9 9
Sepsis 9 9
Pulmonary Edema 8 8
Unspecified Tissue Injury 8 8
Hypovolemia 7 7
Unspecified Kidney or Urinary Problem 5 5
Cardiac Arrest 5 5
Cancer 5 5
Adhesion(s) 5 5
Abdominal Pain 5 5
Urethral Stenosis/Stricture 4 4
Bowel Burn 4 4
Fever 4 4
Tachycardia 4 4
Low Oxygen Saturation 4 4
Superficial (First Degree) Burn 4 4
Hematoma 3 3
Perforation of Vessels 3 3
Thrombus 3 3
Anemia 3 3
Edema 3 3
Rupture 3 3

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 Richard Wolf Medical Instruments Corp. II Jun-13-2019
8 Scholly Fiberoptic Gmbh II Aug-09-2023
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