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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
AURIS HEALTH INC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
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 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY AMERICA
  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

MDR Year MDR Reports MDR Events
2019 207 207
2020 402 402
2021 325 325
2022 455 455
2023 457 457
2024 232 232

Device Problems MDRs with this Device Problem Events in those MDRs
Break 553 553
Microbial Contamination of Device 248 248
Adverse Event Without Identified Device or Use Problem 204 204
Failure to Clean Adequately 150 150
Device Reprocessing Problem 128 128
Mechanical Problem 88 88
Material Protrusion/Extrusion 69 69
No Display/Image 65 65
Poor Quality Image 60 60
Detachment of Device or Device Component 54 54
Peeled/Delaminated 48 48
Material Split, Cut or Torn 47 47
Fluid/Blood Leak 46 46
Contamination 40 40
Appropriate Term/Code Not Available 32 32
Physical Resistance/Sticking 31 31
Material Puncture/Hole 31 31
Material Twisted/Bent 28 28
Mechanical Jam 25 25
Scratched Material 25 25
Contamination /Decontamination Problem 21 21
Material Deformation 20 20
Device Contamination with Chemical or Other Material 20 20
Material Separation 19 19
Corroded 18 18
Leak/Splash 16 16
Crack 15 15
Insufficient Information 14 14
Use of Device Problem 13 13
Defective Device 13 13
Device Displays Incorrect Message 13 13
Defective Component 12 12
Difficult to Remove 12 12
Material Fragmentation 12 12
Unintended Movement 10 10
Melted 9 9
Fracture 8 8
Loose or Intermittent Connection 8 8
Degraded 8 8
Improper or Incorrect Procedure or Method 8 8
Component Missing 8 8
Device Handling Problem 8 8
Material Integrity Problem 7 7
Unsealed Device Packaging 7 7
Failure to Power Up 6 6
Problem with Sterilization 6 6
Material Perforation 6 6
Display or Visual Feedback Problem 6 6
Entrapment of Device 6 6
Erratic or Intermittent Display 6 6
Optical Problem 6 6
Positioning Problem 5 5
Sharp Edges 5 5
Device Damaged by Another Device 5 5
Difficult to Advance 5 5
Misconnection 4 4
Display Difficult to Read 4 4
Dent in Material 4 4
Retraction Problem 4 4
Material Too Rigid or Stiff 3 3
Fitting Problem 3 3
Deformation Due to Compressive Stress 3 3
Labelling, Instructions for Use or Training Problem 3 3
Unexpected Shutdown 3 3
Connection Problem 3 3
Output Problem 3 3
Separation Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Device Dislodged or Dislocated 2 2
Optical Distortion 2 2
Naturally Worn 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
Blocked Connection 2 2
Tear, Rip or Hole in Device Packaging 2 2
Obstruction of Flow 2 2
Structural Problem 1 1
Failure to Advance 1 1
Device Damaged Prior to Use 1 1
Residue After Decontamination 1 1
Separation Failure 1 1
Communication or Transmission Problem 1 1
Vibration 1 1
Stretched 1 1
Unstable 1 1
Material Rupture 1 1
Product Quality Problem 1 1
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1091 1091
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
Laceration(s) 10 10
Perforation 10 10
Hematuria 9 9
Urinary Frequency 8 8
Hemorrhage/Bleeding 8 8
Renal Failure 7 7
Inflammation 6 6
Nausea 5 5
Septic Shock 5 5
Urinary Retention 5 5
Obstruction/Occlusion 5 5
Urethral Stenosis/Stricture 5 5
No Code Available 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Unspecified Tissue Injury 4 4
Chills 4 4
Patient Problem/Medical Problem 4 4
Device Embedded In Tissue or Plaque 3 3
Physical Entrapment 3 3
Discomfort 3 3
Rupture 3 3
Hematoma 3 3
Abrasion 3 3
Abscess 2 2
Death 2 2
Bowel Burn 2 2
Burn(s) 2 2
Hepatitis 2 2
Tissue Damage 2 2
Vomiting 2 2
No Information 2 2
Swelling/ Edema 2 2
Renal Impairment 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
Dysuria 1 1
Increased Respiratory Rate 1 1
Malaise 1 1
Tachycardia 1 1
Excessive Tear Production 1 1
Stenosis 1 1
Internal Organ Perforation 1 1
Device Overstimulation of Tissue 1 1
Abdominal Pain 1 1
Pneumonia 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Low Blood Pressure/ Hypotension 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Chest Pain 1 1
Dyspnea 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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