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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
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 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
OTU MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
TECHNOLOGY DELIVERY SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 12 12
2015 16 16
2016 35 35
2017 142 142
2018 118 118
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 631 631
Microbial Contamination of Device 279 279
Adverse Event Without Identified Device or Use Problem 231 231
Failure to Clean Adequately 150 150
Device Reprocessing Problem 128 128
Mechanical Problem 98 98
No Display/Image 92 92
Material Protrusion/Extrusion 86 86
Poor Quality Image 70 70
Detachment of Device or Device Component 54 54
Peeled/Delaminated 51 51
Fluid/Blood Leak 48 48
Material Split, Cut or Torn 47 47
Contamination 41 41
Leak/Splash 37 37
Material Puncture/Hole 32 32
Physical Resistance/Sticking 32 32
Material Deformation 32 32
Appropriate Term/Code Not Available 32 32
Material Twisted/Bent 28 28
Mechanical Jam 28 28
Contamination /Decontamination Problem 26 26
Scratched Material 25 25
Difficult to Remove 22 22
Material Separation 21 21
Device Contamination with Chemical or Other Material 21 21
Corroded 19 19
Material Fragmentation 19 19
Insufficient Information 18 18
Crack 17 17
Device Displays Incorrect Message 15 15
Defective Device 14 14
Fracture 14 14
Use of Device Problem 14 14
Material Perforation 13 13
Defective Component 13 13
Display or Visual Feedback Problem 12 12
Melted 11 11
Device Handling Problem 10 10
Unintended Movement 10 10
Optical Problem 10 10
Material Integrity Problem 9 9
Device Damaged by Another Device 9 9
Device Operates Differently Than Expected 9 9
Degraded 9 9
Improper or Incorrect Procedure or Method 9 9
Device Damaged Prior to Use 8 8
Component Missing 8 8
Loose or Intermittent Connection 8 8
Unsealed Device Packaging 8 8
Entrapment of Device 8 8
Detachment Of Device Component 8 8
Tear, Rip or Hole in Device Packaging 8 8
Erratic or Intermittent Display 7 7
No Device Output 6 6
Failure to Power Up 6 6
Problem with Sterilization 6 6
Difficult to Advance 6 6
Improper Device Output 5 5
Positioning Problem 5 5
Sharp Edges 5 5
Retraction Problem 5 5
Material Too Rigid or Stiff 5 5
Kinked 5 5
Bent 5 5
Display Difficult to Read 4 4
False Device Output 4 4
Material Frayed 4 4
Misconnection 4 4
Output Problem 4 4
Cut In Material 4 4
Dent in Material 4 4
Deformation Due to Compressive Stress 3 3
Connection Problem 3 3
Device Dislodged or Dislocated 3 3
Unexpected Shutdown 3 3
Separation Problem 3 3
Hole In Material 3 3
Image Display Error/Artifact 3 3
Labelling, Instructions for Use or Training Problem 3 3
Thermal Decomposition of Device 3 3
Fitting Problem 3 3
Sticking 2 2
Product Quality Problem 2 2
Overheating of Device 2 2
Material Rupture 2 2
Loss of Power 2 2
Component Falling 2 2
Loss of or Failure to Bond 2 2
Positioning Failure 2 2
Material Discolored 2 2
Material Invagination 2 2
Optical Distortion 2 2
Power Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 2 2
Device Contaminated During Manufacture or Shipping 2 2
Naturally Worn 2 2
Device Contamination With Biological Material 2 2
Blocked Connection 2 2

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 378 378
No Known Impact Or Consequence To Patient 252 252
Urinary Tract Infection 165 165
No Patient Involvement 149 149
Fever 78 78
Unspecified Infection 77 77
Injury 48 48
Insufficient Information 40 40
Pain 29 29
Foreign Body In Patient 27 27
Bacterial Infection 21 21
Perforation 20 20
Unspecified Kidney or Urinary Problem 20 20
Sepsis 18 18
Laceration(s) 15 15
No Code Available 14 14
Device Embedded In Tissue or Plaque 9 9
Hematuria 9 9
Urinary Frequency 8 8
Inflammation 8 8
Hemorrhage/Bleeding 8 8
Renal Failure 8 8
Tissue Damage 7 7
No Information 7 7
Septic Shock 6 6
Urinary Retention 5 5
Nausea 5 5
Patient Problem/Medical Problem 5 5
Urethral Stenosis/Stricture 5 5
Rupture 5 5
Obstruction/Occlusion 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Unspecified Tissue Injury 4 4
Chills 4 4
Hematoma 4 4
Abrasion 3 3
Excessive Tear Production 3 3
Physical Entrapment 3 3
Discomfort 3 3
Swelling/ Edema 2 2
Renal Impairment 2 2
Abscess 2 2
Death 2 2
Bowel Burn 2 2
Burn(s) 2 2
Hepatitis 2 2
Vomiting 2 2
Internal Organ Perforation 2 2
Device Overstimulation of Tissue 1 1
Abdominal Pain 1 1
Pneumonia 1 1
Pneumothorax 1 1
Pulmonary Edema 1 1
Uterine Perforation 1 1
Tachycardia 1 1
Low Blood Pressure/ Hypotension 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Chest Pain 1 1
Dyspnea 1 1
Edema 1 1
Arrhythmia 1 1
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
Complaint, Ill-Defined 1 1
Stenosis 1 1
Increased Respiratory Rate 1 1
Malaise 1 1
Blood Loss 1 1
Intraoperative Pain 1 1
Dysuria 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
4 Olympus Corporation of the Americas II Jul-20-2018
5 Pentax Medical Company II Jun-28-2016
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