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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 763 763

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1615 1615
Adverse Event Without Identified Device or Use Problem 407 407
Detachment of Device or Device Component 324 324
Material Fragmentation 101 101
Crack 83 83
Mechanical Problem 72 72
Material Separation 62 62
Poor Quality Image 50 50
Component Missing 49 49
Material Integrity Problem 45 45
Loose or Intermittent Connection 41 41
Fracture 40 40
Material Protrusion/Extrusion 39 39
Insufficient Information 32 32
Use of Device Problem 28 28
Material Deformation 27 27
Defective Device 24 24
Microbial Contamination of Device 23 23
Material Twisted/Bent 22 22
Mechanical Jam 21 21
Scratched Material 21 21
No Display/Image 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
Material Split, Cut or Torn 14 14
Suction Problem 14 14
Fail-Safe Problem 13 13
Optical Problem 11 11
Device Fell 11 11
Device Reprocessing Problem 10 10
Material Opacification 9 9
Material Puncture/Hole 8 8
Melted 8 8
Sharp Edges 8 8
Connection Problem 7 7
Dull, Blunt 7 7
Dent in Material 7 7
Energy Output Problem 6 6
Material Disintegration 6 6
Sparking 6 6
Flare or Flash 6 6
Unintended Movement 6 6
Therapeutic or Diagnostic Output Failure 5 5
Noise, Audible 5 5
Physical Resistance/Sticking 5 5
Failure to Clean Adequately 5 5
Contamination 5 5
Leak/Splash 5 5
Disconnection 5 5
Fluid/Blood Leak 5 5
Corroded 4 4
Peeled/Delaminated 4 4
Delivered as Unsterile Product 4 4
Tear, Rip or Hole in Device Packaging 4 4
Improper or Incorrect Procedure or Method 4 4
Excessive Heating 4 4
Difficult or Delayed Activation 4 4
Arcing 3 3
Device Displays Incorrect Message 3 3
Device Dislodged or Dislocated 3 3
Naturally Worn 3 3
Activation Problem 3 3
Separation Problem 3 3
Difficult to Remove 3 3
Material Discolored 3 3
Entrapment of Device 3 3
Image Display Error/Artifact 3 3
Difficult to Insert 2 2
Fogging 2 2
Flaked 2 2
Unintended Ejection 2 2
Display Difficult to Read 2 2
Electrical /Electronic Property Problem 2 2
Degraded 2 2
Thermal Decomposition of Device 2 2
Device Slipped 2 2
Product Quality Problem 2 2
Device Damaged Prior to Use 2 2
Failure to Align 2 2
Failure to Advance 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
Contamination /Decontamination Problem 2 2
Failure to Obtain Sample 2 2
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Communication or Transmission Problem 1 1
Device Markings/Labelling Problem 1 1
Optical Obstruction 1 1
Mechanics Altered 1 1
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1
Human-Device Interface Problem 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2227 2227
Uterine Perforation 193 193
Foreign Body In Patient 143 143
No Consequences Or Impact To Patient 134 134
Insufficient Information 118 118
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 40 40
Perforation 19 19
No Code Available 18 18
No Information 15 15
Device Embedded In Tissue or Plaque 14 14
Blood Loss 13 13
Pain 10 10
Patient Problem/Medical Problem 9 9
Internal Organ Perforation 9 9
Bacterial Infection 9 9
Burn(s) 8 8
Unspecified Infection 8 8
Laceration(s) 8 8
Unspecified Tissue Injury 8 8
Death 6 6
Tissue Damage 6 6
Sepsis 5 5
Adhesion(s) 5 5
Unspecified Kidney or Urinary Problem 5 5
Urethral Stenosis/Stricture 4 4
Bowel Burn 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
Unspecified Gastrointestinal Problem 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
Infiltration into Tissue 2 2
Low Blood Pressure/ Hypotension 2 2
Burn, Thermal 2 2
Cough 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
Choking 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
Hypoventilation 1 1
Failure of Implant 1 1
Incontinence 1 1
Menstrual Irregularities 1 1
Nausea 1 1
Necrosis 1 1
Inflammation 1 1
Pulmonary Edema 1 1
Rash 1 1
Scar Tissue 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
Hyponatremia 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 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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