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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
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
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
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 355 355

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1745 1745
Adverse Event Without Identified Device or Use Problem 507 507
Detachment of Device or Device Component 279 279
Insufficient Information 123 123
Material Fragmentation 119 119
Material Separation 103 103
Mechanical Problem 87 87
Device Operates Differently Than Expected 76 76
Crack 70 70
Poor Quality Image 53 53
Component Missing 50 50
Detachment Of Device Component 47 47
Fracture 43 43
Material Opacification 36 36
Material Protrusion/Extrusion 34 34
Mechanical Jam 34 34
Appropriate Term/Code Not Available 34 34
Material Deformation 29 29
Material Integrity Problem 29 29
Use of Device Problem 28 28
Loose or Intermittent Connection 27 27
No Display/Image 26 26
Defective Device 25 25
Microbial Contamination of Device 24 24
Failure to Cut 22 22
Metal Shedding Debris 21 21
Suction Problem 21 21
Mechanics Altered 19 19
Scratched Material 19 19
Noise, Audible 18 18
Material Twisted/Bent 17 17
Defective Component 17 17
Bent 17 17
Incorrect Measurement 17 17
Improper or Incorrect Procedure or Method 16 16
Intermittent Energy Output 16 16
Material Split, Cut or Torn 14 14
Fail-Safe Problem 13 13
Fluid/Blood Leak 13 13
Component Falling 12 12
Device Inoperable 12 12
Unintended Movement 11 11
Device Fell 11 11
Device Handling Problem 10 10
Leak/Splash 10 10
Overheating of Device 9 9
Smoking 9 9
Connection Problem 9 9
Dull, Blunt 9 9
Dent in Material 9 9
Optical Problem 9 9
Therapeutic or Diagnostic Output Failure 8 8
Device Displays Incorrect Message 8 8
Device Slipped 8 8
Material Puncture/Hole 8 8
Device Reprocessing Problem 8 8
Material Disintegration 7 7
Flare or Flash 7 7
Device Dislodged or Dislocated 6 6
Electrical Shorting 6 6
Sparking 6 6
Contamination 6 6
Difficult to Insert 6 6
Product Quality Problem 6 6
Difficult to Remove 6 6
Energy Output Problem 6 6
Melted 6 6
Physical Resistance/Sticking 6 6
Sharp Edges 5 5
Fire 5 5
Device Damaged Prior to Use 5 5
Difficult to Open or Close 5 5
Device Contamination with Chemical or Other Material 4 4
Tear, Rip or Hole in Device Packaging 4 4
Other (for use when an appropriate device code cannot be identified) 4 4
Material Perforation 4 4
Difficult or Delayed Activation 4 4
Disconnection 4 4
Image Display Error/Artifact 4 4
Delivered as Unsterile Product 4 4
Device Emits Odor 4 4
Device Difficult to Setup or Prepare 4 4
Temperature Problem 4 4
Positioning Problem 4 4
Excessive Heating 4 4
Activation Problem 3 3
Separation Problem 3 3
Loss of Power 3 3
Sticking 3 3
Entrapment of Device 3 3
Corroded 3 3
Thermal Decomposition of Device 3 3
Material Discolored 3 3
Failure to Advance 3 3
Overfill 3 3
Improper Flow or Infusion 3 3
Infusion or Flow Problem 3 3
Naturally Worn 3 3
Device Packaging Compromised 3 3
Device Or Device Fragments Location Unknown 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1863 1863
No Known Impact Or Consequence To Patient 414 415
No Consequences Or Impact To Patient 346 346
Uterine Perforation 240 240
Foreign Body In Patient 146 146
No Patient Involvement 146 146
Insufficient Information 105 105
Hemorrhage/Bleeding 89 89
Perforation 87 87
No Code Available 62 62
No Information 52 52
Bowel Perforation 52 52
Device Embedded In Tissue or Plaque 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Blood Loss 26 26
Internal Organ Perforation 21 21
Tissue Damage 20 20
Injury 20 20
Hypervolemia 15 15
Pain 15 15
Death 13 13
Unspecified Infection 11 11
Burn(s) 11 11
Patient Problem/Medical Problem 11 11
Complaint, Ill-Defined 11 11
Abdominal Distention 10 10
Air Embolism 10 10
Bacterial Infection 9 9
Laceration(s) 8 8
Sepsis 8 8
Pulmonary Edema 7 7
Hypovolemia 7 7
Unspecified Tissue Injury 7 7
Unspecified Kidney or Urinary Problem 5 5
Cancer 5 5
Cardiac Arrest 5 5
Adhesion(s) 5 5
Abdominal Pain 5 5
Bowel Burn 4 4
Tachycardia 4 4
Urethral Stenosis/Stricture 4 4
Superficial (First Degree) Burn 4 4
Low Oxygen Saturation 4 4
Discomfort 3 3
Radiation Exposure, Unintended 3 3
Unintended Radiation Exposure 3 3
Thrombus 3 3
Nonresorbable materials, unretrieved in body 3 3
Rupture 3 3
Incomplete Induced Abortion 3 3
Hematoma 3 3
Vaginal Mucosa Damage 3 3
Perforation of Vessels 3 3
Bleeding 3 3
Bradycardia 3 3
Anemia 3 3
Edema 3 3
Fever 3 3
Emotional Changes 2 2
Dyspnea 2 2
Ecchymosis 2 2
Infiltration into Tissue 2 2
Low Blood Pressure/ Hypotension 2 2
Hypoxia 2 2
Atrial Fibrillation 2 2
Cardiopulmonary Arrest 2 2
Urinary Tract Infection 2 2
Discharge 2 2
Peritonitis 2 2
Respiratory Distress 2 2
Menstrual Irregularities 2 2
Cancer Cells Dissemination 2 2
Muscle/Tendon Damage 2 2
Easy Bruising 2 2
Fluid Discharge 2 2
Fibrosis 2 2
Unspecified Gastrointestinal Problem 2 2
Breathing difficulties 2 2
Skin Tears 2 2
Burn, Thermal 2 2
Vaso-Vagal Response 2 2
Weight Changes 1 1
Underdose 1 1
Surgical procedure, additional 1 1
Treatment with medication(s) 1 1
Chest Tightness/Pressure 1 1
Malaise 1 1
Depression 1 1
Disability 1 1
Hyponatremia 1 1
Not Applicable 1 1
Intermenstrual Bleeding 1 1
Heavier Menses 1 1
Blister 1 1
Genital Bleeding 1 1
Spontaneous Abortion 1 1
Solid Tumour 1 1
Urinary Incontinence 1 1
Muscle Spasm(s) 1 1
Myocardial Infarction 1 1

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 Aug-29-2023
6 Richard Wolf Medical Instruments Corp. II Jun-13-2019
7 Scholly Fiberoptic Gmbh II Aug-09-2023
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