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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ureteroscope and accessories, flexible/rigid
Definition To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeFGB
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AMBU A/S
  SUBSTANTIALLY EQUIVALENT 1
AURIS HEALTH INC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION -
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU RED PINE MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC
  SUBSTANTIALLY EQUIVALENT 1
HUGER MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOVISION, INC
  SUBSTANTIALLY EQUIVALENT 1
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 207 207
2020 402 402
2021 325 325
2022 455 455
2023 457 457
2024 308 308

Device Problems MDRs with this Device Problem Events in those MDRs
Break 568 568
Microbial Contamination of Device 250 250
Adverse Event Without Identified Device or Use Problem 205 205
Failure to Clean Adequately 160 160
Device Reprocessing Problem 131 131
Mechanical Problem 93 93
Material Protrusion/Extrusion 70 70
No Display/Image 66 66
Poor Quality Image 62 62
Detachment of Device or Device Component 58 58
Material Split, Cut or Torn 49 49
Peeled/Delaminated 49 49
Fluid/Blood Leak 46 46
Contamination 41 41
Physical Resistance/Sticking 33 33
Appropriate Term/Code Not Available 32 32
Material Puncture/Hole 32 32
Material Twisted/Bent 30 30
Mechanical Jam 25 25
Scratched Material 25 25
Material Deformation 22 22
Device Contamination with Chemical or Other Material 22 22
Material Separation 21 21
Contamination /Decontamination Problem 21 21
Corroded 19 19
Crack 18 18
Leak/Splash 16 16
Device Displays Incorrect Message 14 14
Defective Component 14 14
Insufficient Information 14 14
Defective Device 13 13
Use of Device Problem 13 13
Material Fragmentation 13 13
Difficult to Remove 12 12
Optical Problem 12 12
Unintended Movement 10 10
Unsealed Device Packaging 10 10
Component Missing 10 10
Improper or Incorrect Procedure or Method 9 9
Melted 9 9
Degraded 9 9
Fracture 8 8
Loose or Intermittent Connection 8 8
Device Handling Problem 8 8
Material Integrity Problem 7 7
Erratic or Intermittent Display 6 6
Display or Visual Feedback Problem 6 6
Entrapment of Device 6 6
Problem with Sterilization 6 6
Failure to Power Up 6 6
Material Perforation 6 6
Device Damaged by Another Device 5 5
Difficult to Advance 5 5
Positioning Problem 5 5
Sharp Edges 5 5
Dent in Material 4 4
Retraction Problem 4 4
Fitting Problem 4 4
Display Difficult to Read 4 4
Misconnection 4 4
Labelling, Instructions for Use or Training Problem 3 3
Material Too Rigid or Stiff 3 3
Unexpected Shutdown 3 3
Separation Problem 3 3
Output Problem 3 3
Deformation Due to Compressive Stress 3 3
Connection Problem 3 3
Naturally Worn 2 2
Device Dislodged or Dislocated 2 2
No Apparent Adverse Event 2 2
Therapeutic or Diagnostic Output Failure 2 2
Optical Distortion 2 2
Blocked Connection 2 2
Tear, Rip or Hole in Device Packaging 2 2
Obstruction of Flow 2 2
Material Frayed 2 2
Image Display Error/Artifact 2 2
Overheating of Device 2 2
Loss of or Failure to Bond 2 2
Positioning Failure 2 2
Material Discolored 2 2
Thermal Decomposition of Device 2 2
Signal Artifact/Noise 1 1
Biofilm coating in Device 1 1
Fogging 1 1
Difficult to Fold, Unfold or Collapse 1 1
Material Erosion 1 1
Pitted 1 1
Loss of Power 1 1
Nonstandard Device 1 1
Delivered as Unsterile Product 1 1
Gel Leak 1 1
Material Invagination 1 1
Structural Problem 1 1
Failure to Advance 1 1
Device Damaged Prior to Use 1 1
Residue After Decontamination 1 1
Communication or Transmission Problem 1 1
Separation Failure 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1166 1166
No Consequences Or Impact To Patient 294 294
Urinary Tract Infection 165 165
No Known Impact Or Consequence To Patient 135 135
No Patient Involvement 107 107
Fever 75 75
Unspecified Infection 73 73
Insufficient Information 40 40
Pain 28 28
Injury 26 26
Foreign Body In Patient 20 20
Unspecified Kidney or Urinary Problem 20 20
Sepsis 18 18
Bacterial Infection 18 18
Perforation 10 10
Laceration(s) 10 10
Hematuria 9 9
Urinary Frequency 8 8
Hemorrhage/Bleeding 8 8
Renal Failure 7 7
Inflammation 6 6
Septic Shock 5 5
Urinary Retention 5 5
Nausea 5 5
Obstruction/Occlusion 5 5
Urethral Stenosis/Stricture 5 5
No Code Available 5 5
Chills 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Unspecified Tissue Injury 4 4
Patient Problem/Medical Problem 4 4
Physical Entrapment 3 3
Discomfort 3 3
Rupture 3 3
Device Embedded In Tissue or Plaque 3 3
Hematoma 3 3
Abrasion 3 3
Abscess 2 2
Bowel Burn 2 2
Burn(s) 2 2
Death 2 2
Hepatitis 2 2
Tissue Damage 2 2
Vomiting 2 2
No Information 2 2
Renal Impairment 2 2
Swelling/ Edema 2 2
Cramp(s) /Muscle Spasm(s) 1 1
Drug Resistant Bacterial Infection 1 1
Unspecified Blood or Lymphatic problem 1 1
Thrombosis/Thrombus 1 1
Unspecified Heart Problem 1 1
Unspecified Gastrointestinal Problem 1 1
Excessive Tear Production 1 1
Stenosis 1 1
Malaise 1 1
Dysuria 1 1
Increased Respiratory Rate 1 1
Abdominal Distention 1 1
Tachycardia 1 1
Abdominal Pain 1 1
Internal Organ Perforation 1 1
Device Overstimulation of Tissue 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Pneumonia 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Low Blood Pressure/ Hypotension 1 1
Dyspnea 1 1
Chest Pain 1 1
Adult Respiratory Distress Syndrome 1 1
Arrhythmia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aizu Olympus Co., Ltd. II Nov-17-2023
2 Karl Storz Endoscopy II May-12-2022
3 Olympus Corporation of the Americas II Jun-13-2022
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