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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 613 613

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1538 1538
Adverse Event Without Identified Device or Use Problem 398 398
Detachment of Device or Device Component 299 299
Material Fragmentation 99 99
Crack 79 79
Mechanical Problem 72 72
Material Separation 62 62
Poor Quality Image 49 49
Component Missing 46 46
Fracture 38 38
Material Protrusion/Extrusion 38 38
Material Integrity Problem 36 36
Loose or Intermittent Connection 35 35
Insufficient Information 31 31
Material Deformation 27 27
Use of Device Problem 26 26
Defective Device 24 24
Microbial Contamination of Device 23 23
Material Twisted/Bent 21 21
Mechanical Jam 20 20
Scratched Material 20 20
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
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
Melted 7 7
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
Fluid/Blood Leak 5 5
Noise, Audible 5 5
Therapeutic or Diagnostic Output Failure 5 5
Physical Resistance/Sticking 5 5
Sharp Edges 5 5
Excessive Heating 4 4
Difficult or Delayed Activation 4 4
Disconnection 4 4
Corroded 4 4
Peeled/Delaminated 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
Material Discolored 3 3
Entrapment of Device 3 3
Image Display Error/Artifact 3 3
Arcing 3 3
Device Displays Incorrect Message 3 3
Device Dislodged or Dislocated 3 3
Activation Problem 3 3
Separation Problem 3 3
Failure to Clean Adequately 3 3
Naturally Worn 3 3
Complete Loss of Power 2 2
Temperature Problem 2 2
Device Handling Problem 2 2
Device Damaged by Another Device 2 2
Output Problem 2 2
Contamination /Decontamination Problem 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
Thermal Decomposition of Device 2 2
Device Damaged Prior to Use 2 2
Failure to Align 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
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
Nonstandard Device 1 1
Expiration Date Error 1 1
Failure to Calibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2096 2096
Uterine Perforation 191 191
No Consequences Or Impact To Patient 134 134
Foreign Body In Patient 132 132
Insufficient Information 114 114
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
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
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 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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