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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 498 498

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1459 1459
Adverse Event Without Identified Device or Use Problem 392 392
Detachment of Device or Device Component 290 290
Material Fragmentation 99 99
Crack 75 75
Mechanical Problem 71 71
Material Separation 62 62
Poor Quality Image 49 49
Component Missing 44 44
Fracture 38 38
Material Protrusion/Extrusion 37 37
Material Integrity Problem 32 32
Insufficient Information 31 31
Loose or Intermittent Connection 31 31
Material Deformation 27 27
Use of Device Problem 26 26
Defective Device 24 24
Microbial Contamination of Device 23 23
No Display/Image 20 20
Material Twisted/Bent 20 20
Mechanical Jam 20 20
Scratched Material 20 20
Appropriate Term/Code Not Available 18 18
Intermittent Energy Output 17 17
Incorrect Measurement 17 17
Defective Component 15 15
Failure to Cut 15 15
Suction Problem 14 14
Fail-Safe Problem 13 13
Material Split, Cut or Torn 13 13
Device Fell 11 11
Optical Problem 9 9
Material Opacification 9 9
Material Puncture/Hole 8 8
Device Reprocessing Problem 8 8
Dent in Material 7 7
Dull, Blunt 7 7
Connection Problem 7 7
Flare or Flash 6 6
Sparking 6 6
Unintended Movement 6 6
Energy Output Problem 6 6
Material Disintegration 6 6
Contamination 5 5
Leak/Splash 5 5
Melted 5 5
Fluid/Blood Leak 5 5
Therapeutic or Diagnostic Output Failure 5 5
Physical Resistance/Sticking 5 5
Sharp Edges 5 5
Noise, Audible 5 5
Excessive Heating 4 4
Difficult or Delayed Activation 4 4
Disconnection 4 4
Corroded 4 4
Delivered as Unsterile Product 4 4
Improper or Incorrect Procedure or Method 4 4
Tear, Rip or Hole in Device Packaging 4 4
Peeled/Delaminated 3 3
Material Discolored 3 3
Entrapment of Device 3 3
Image Display Error/Artifact 3 3
Device Displays Incorrect Message 3 3
Naturally Worn 3 3
Activation Problem 3 3
Separation Problem 3 3
Failure to Clean Adequately 2 2
Complete Loss of Power 2 2
Device Handling Problem 2 2
Temperature Problem 2 2
Output Problem 2 2
Device Damaged by Another Device 2 2
Device Dislodged or Dislocated 2 2
Contamination /Decontamination Problem 2 2
Failure to Obtain Sample 2 2
Difficult to Insert 2 2
Flaked 2 2
Fogging 2 2
Unintended Ejection 2 2
Display Difficult to Read 2 2
Electrical /Electronic Property Problem 2 2
Degraded 2 2
Difficult to Remove 2 2
Product Quality Problem 2 2
Device Damaged Prior to Use 2 2
Failure to Advance 2 2
Expiration Date Error 1 1
Failure to Calibrate 1 1
Structural Problem 1 1
Failure to Align 1 1
Arcing of Electrodes 1 1
Insufficient Flow or Under Infusion 1 1
Reflux within Device 1 1
Vibration 1 1
Device Slipped 1 1
Problem with Sterilization 1 1
Loss of Power 1 1
Device Difficult to Setup or Prepare 1 1
Decrease in Pressure 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1991 1991
Uterine Perforation 187 187
No Consequences Or Impact To Patient 134 134
Foreign Body In Patient 130 130
Insufficient Information 110 110
No Patient Involvement 70 70
No Known Impact Or Consequence To Patient 65 65
Bowel Perforation 41 41
Hemorrhage/Bleeding 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Perforation 19 19
No Code Available 18 18
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
Pain 9 9
Bacterial Infection 9 9
Unspecified Infection 8 8
Laceration(s) 8 8
Burn(s) 7 7
Unspecified Tissue Injury 7 7
Death 6 6
Tissue Damage 6 6
Adhesion(s) 5 5
Unspecified Kidney or Urinary Problem 5 5
Urethral Stenosis/Stricture 4 4
Bowel Burn 4 4
Sepsis 4 4
Superficial (First Degree) Burn 4 4
Abdominal Distention 4 4
Hypervolemia 4 4
Cancer 3 3
Vaginal Mucosa Damage 3 3
Rupture 3 3
Incomplete Induced Abortion 3 3
Discomfort 3 3
Injury 3 3
Air Embolism 3 3
Bradycardia 3 3
Abdominal Pain 3 3
Fever 3 3
Unintended Radiation Exposure 3 3
Easy Bruising 2 2
Burn, Thermal 2 2
Muscle/Tendon Damage 2 2
Cancer Cells Dissemination 2 2
Dyspnea 2 2
Ecchymosis 2 2
Anemia 2 2
Atrial Fibrillation 2 2
Low Blood Pressure/ Hypotension 2 2
Infiltration into Tissue 2 2
Unspecified Gastrointestinal Problem 2 2
Hyponatremia 1 1
Not Applicable 1 1
Radiation Exposure, Unintended 1 1
Intermenstrual Bleeding 1 1
Weight Changes 1 1
Fluid Discharge 1 1
Chest Tightness/Pressure 1 1
Skin Tears 1 1
Convulsion, Tonic 1 1
Distress 1 1
Perforation of Vessels 1 1
Cramp(s) 1 1
Tachycardia 1 1
Thrombus 1 1
Inflammation 1 1
Pulmonary Edema 1 1
Rash 1 1
Scar Tissue 1 1
Failure of Implant 1 1
Incontinence 1 1
Menstrual Irregularities 1 1
Nausea 1 1
Necrosis 1 1
Pulmonary Embolism 1 1
Edema 1 1
Embolism 1 1
Hematoma 1 1
Cardiac Arrest 1 1
Cyanosis 1 1
Solid Tumour 1 1
Blister 1 1
Genital Bleeding 1 1
Spontaneous Abortion 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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