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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 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOPERSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
CORINTH MEDTECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOLOGIC, INC.
  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
MEDITRINA, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
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 1380 1380
Adverse Event Without Identified Device or Use Problem 386 386
Detachment of Device or Device Component 272 272
Material Fragmentation 98 98
Mechanical Problem 70 70
Crack 66 66
Material Separation 62 62
Poor Quality Image 49 49
Component Missing 39 39
Fracture 37 37
Material Protrusion/Extrusion 34 34
Insufficient Information 31 31
Material Deformation 27 27
Material Integrity Problem 27 27
Loose or Intermittent Connection 25 25
Defective Device 24 24
Microbial Contamination of Device 23 23
Use of Device Problem 22 22
No Display/Image 20 20
Mechanical Jam 20 20
Scratched Material 18 18
Appropriate Term/Code Not Available 17 17
Material Twisted/Bent 17 17
Incorrect Measurement 17 17
Intermittent Energy Output 16 16
Failure to Cut 15 15
Defective Component 14 14
Suction Problem 13 13
Fail-Safe Problem 13 13
Material Split, Cut or Torn 13 13
Device Fell 11 11
Optical Problem 9 9
Material Opacification 8 8
Material Puncture/Hole 8 8
Device Reprocessing Problem 8 8
Dull, Blunt 7 7
Dent in Material 7 7
Connection Problem 7 7
Sparking 6 6
Flare or Flash 6 6
Unintended Movement 6 6
Energy Output Problem 6 6
Material Disintegration 6 6
Fluid/Blood Leak 5 5
Contamination 5 5
Leak/Splash 5 5
Melted 5 5
Noise, Audible 5 5
Physical Resistance/Sticking 5 5
Sharp Edges 5 5
Therapeutic or Diagnostic Output Failure 5 5
Excessive Heating 4 4
Delivered as Unsterile Product 4 4
Disconnection 4 4
Improper or Incorrect Procedure or Method 4 4
Tear, Rip or Hole in Device Packaging 4 4
Difficult or Delayed Activation 4 4
Material Discolored 3 3
Corroded 3 3
Entrapment of Device 3 3
Image Display Error/Artifact 3 3
Naturally Worn 3 3
Activation Problem 3 3
Separation Problem 3 3
Device Displays Incorrect Message 3 3
Contamination /Decontamination Problem 2 2
Output Problem 2 2
Device Damaged by Another Device 2 2
Device Dislodged or Dislocated 2 2
Failure to Clean Adequately 2 2
Temperature Problem 2 2
Device Handling Problem 2 2
Complete Loss of Power 2 2
Difficult to Insert 2 2
Flaked 2 2
Display Difficult to Read 2 2
Fogging 2 2
Unintended Ejection 2 2
Failure to Advance 2 2
Failure to Obtain Sample 2 2
Device Damaged Prior to Use 2 2
Difficult to Remove 2 2
Product Quality Problem 2 2
Peeled/Delaminated 2 2
Loss of Power 1 1
Device Difficult to Setup or Prepare 1 1
Decrease in Pressure 1 1
Reflux within Device 1 1
Overheating of Device 1 1
Insufficient Flow or Under Infusion 1 1
Vibration 1 1
Device Slipped 1 1
Problem with Sterilization 1 1
Arcing of Electrodes 1 1
Failure to Calibrate 1 1
Structural Problem 1 1
Failure to Align 1 1
Arcing 1 1
Expiration Date Error 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1863 1863
Uterine Perforation 184 184
No Consequences Or Impact To Patient 134 134
Foreign Body In Patient 129 129
Insufficient Information 105 105
No Patient Involvement 70 70
No Known Impact Or Consequence To Patient 65 65
Bowel Perforation 41 41
Hemorrhage/Bleeding 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
No Code Available 18 18
Perforation 17 17
No Information 15 15
Device Embedded In Tissue or Plaque 14 14
Blood Loss 13 13
Patient Problem/Medical Problem 9 9
Internal Organ Perforation 9 9
Bacterial Infection 9 9
Pain 8 8
Unspecified Infection 8 8
Laceration(s) 8 8
Unspecified Tissue Injury 7 7
Death 6 6
Burn(s) 6 6
Tissue Damage 6 6
Adhesion(s) 5 5
Unspecified Kidney or Urinary Problem 5 5
Urethral Stenosis/Stricture 4 4
Sepsis 4 4
Bowel Burn 4 4
Abdominal Distention 4 4
Superficial (First Degree) Burn 4 4
Hypervolemia 4 4
Cancer 3 3
Discomfort 3 3
Injury 3 3
Rupture 3 3
Incomplete Induced Abortion 3 3
Vaginal Mucosa Damage 3 3
Bradycardia 3 3
Abdominal Pain 3 3
Unintended Radiation Exposure 3 3
Easy Bruising 2 2
Cancer Cells Dissemination 2 2
Muscle/Tendon Damage 2 2
Air Embolism 2 2
Anemia 2 2
Atrial Fibrillation 2 2
Fever 2 2
Dyspnea 2 2
Ecchymosis 2 2
Infiltration into Tissue 2 2
Low Blood Pressure/ Hypotension 2 2
Unspecified Gastrointestinal Problem 2 2
Burn, Thermal 2 2
Not Applicable 1 1
Hyponatremia 1 1
Intermenstrual Bleeding 1 1
Fluid Discharge 1 1
Radiation Exposure, Unintended 1 1
Perforation of Vessels 1 1
Cramp(s) 1 1
Convulsion, Tonic 1 1
Distress 1 1
Chest Tightness/Pressure 1 1
Skin Tears 1 1
Weight Changes 1 1
Failure of Implant 1 1
Incontinence 1 1
Menstrual Irregularities 1 1
Nausea 1 1
Necrosis 1 1
Inflammation 1 1
Tachycardia 1 1
Thrombus 1 1
Rash 1 1
Scar Tissue 1 1
Edema 1 1
Embolism 1 1
Hematoma 1 1
Cardiac Arrest 1 1
Cyanosis 1 1
Pulmonary Embolism 1 1
Blister 1 1
Genital Bleeding 1 1
Spontaneous Abortion 1 1
Solid Tumour 1 1
Urinary Incontinence 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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