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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
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 100 100

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1225 1225
Adverse Event Without Identified Device or Use Problem 373 373
Detachment of Device or Device Component 237 237
Material Fragmentation 95 95
Mechanical Problem 68 68
Material Separation 62 62
Crack 60 60
Poor Quality Image 47 47
Component Missing 37 37
Fracture 36 36
Material Protrusion/Extrusion 32 32
Insufficient Information 26 26
Material Deformation 25 25
Material Integrity Problem 25 25
Defective Device 24 24
Microbial Contamination of Device 22 22
Use of Device Problem 22 22
Loose or Intermittent Connection 21 21
No Display/Image 20 20
Mechanical Jam 20 20
Appropriate Term/Code Not Available 17 17
Incorrect Measurement 17 17
Intermittent Energy Output 16 16
Failure to Cut 15 15
Material Twisted/Bent 14 14
Scratched Material 14 14
Material Split, Cut or Torn 13 13
Fail-Safe Problem 13 13
Defective Component 13 13
Suction Problem 13 13
Device Fell 11 11
Optical Problem 9 9
Material Opacification 8 8
Device Reprocessing Problem 8 8
Dull, Blunt 7 7
Connection Problem 7 7
Sparking 6 6
Unintended Movement 6 6
Dent in Material 6 6
Energy Output Problem 6 6
Contamination 5 5
Material Disintegration 5 5
Fluid/Blood Leak 5 5
Noise, Audible 5 5
Therapeutic or Diagnostic Output Failure 5 5
Physical Resistance/Sticking 5 5
Flare or Flash 5 5
Difficult or Delayed Activation 4 4
Sharp Edges 4 4
Disconnection 4 4
Leak/Splash 4 4
Delivered as Unsterile Product 4 4
Melted 4 4
Improper or Incorrect Procedure or Method 4 4
Tear, Rip or Hole in Device Packaging 4 4
Image Display Error/Artifact 3 3
Material Discolored 3 3
Entrapment of Device 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
Device Damaged by Another Device 2 2
Device Dislodged or Dislocated 2 2
Output Problem 2 2
Temperature Problem 2 2
Device Handling Problem 2 2
Display Difficult to Read 2 2
Fogging 2 2
Unintended Ejection 2 2
Corroded 2 2
Difficult to Insert 2 2
Flaked 2 2
Failure to Advance 2 2
Failure to Obtain Sample 2 2
Difficult to Remove 2 2
Product Quality Problem 2 2
Reflux within Device 1 1
Device Slipped 1 1
Problem with Sterilization 1 1
Vibration 1 1
Overheating of Device 1 1
Peeled/Delaminated 1 1
Loss of Power 1 1
Device Difficult to Setup or Prepare 1 1
Decrease in Pressure 1 1
Material Puncture/Hole 1 1
Expiration Date Error 1 1
Failure to Calibrate 1 1
Structural Problem 1 1
Failure to Align 1 1
Insufficient Flow or Under Infusion 1 1
Device Damaged Prior to Use 1 1
Arcing of Electrodes 1 1
Gas Output Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1644 1644
Uterine Perforation 178 178
No Consequences Or Impact To Patient 134 134
Foreign Body In Patient 115 115
Insufficient Information 96 96
No Patient Involvement 70 70
No Known Impact Or Consequence To Patient 65 65
Bowel Perforation 38 38
Hemorrhage/Bleeding 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
No Code Available 18 18
No Information 15 15
Perforation 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
Laceration(s) 8 8
Unspecified Infection 7 7
Pain 7 7
Tissue Damage 6 6
Burn(s) 6 6
Death 6 6
Adhesion(s) 5 5
Unspecified Kidney or Urinary Problem 5 5
Unspecified Tissue Injury 5 5
Urethral Stenosis/Stricture 4 4
Abdominal Distention 4 4
Hypervolemia 4 4
Bowel Burn 4 4
Sepsis 4 4
Bradycardia 3 3
Abdominal Pain 3 3
Discomfort 3 3
Injury 3 3
Incomplete Induced Abortion 3 3
Vaginal Mucosa Damage 3 3
Cancer 3 3
Unintended Radiation Exposure 3 3
Easy Bruising 2 2
Muscle/Tendon Damage 2 2
Cancer Cells Dissemination 2 2
Unspecified Gastrointestinal Problem 2 2
Burn, Thermal 2 2
Superficial (First Degree) Burn 2 2
Rupture 2 2
Air Embolism 2 2
Anemia 2 2
Atrial Fibrillation 2 2
Dyspnea 2 2
Ecchymosis 2 2
Low Blood Pressure/ Hypotension 2 2
Infiltration into Tissue 2 2
Inflammation 1 1
Cardiac Arrest 1 1
Cyanosis 1 1
Menstrual Irregularities 1 1
Nausea 1 1
Necrosis 1 1
Tachycardia 1 1
Thrombus 1 1
Rash 1 1
Scar Tissue 1 1
Failure of Implant 1 1
Incontinence 1 1
Edema 1 1
Embolism 1 1
Fever 1 1
Hematoma 1 1
Pulmonary Embolism 1 1
Convulsion, Tonic 1 1
Perforation of Vessels 1 1
Cramp(s) 1 1
Chest Tightness/Pressure 1 1
Skin Tears 1 1
Intermenstrual Bleeding 1 1
Weight Changes 1 1
Fluid Discharge 1 1
Not Applicable 1 1
Radiation Exposure, Unintended 1 1
Genital Bleeding 1 1
Spontaneous Abortion 1 1
Hyponatremia 1 1
Solid Tumour 1 1
Blister 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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