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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
Regulation Description Endoscope and accessories.
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
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
  1.  K172246  OLYMPUS URF-V2/V2R
  2.  K172298  OLYMPUS URF-P6/P6R
  3.  K181451  URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETER ...
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 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 35 35
2017 142 142
2018 118 118
2019 207 207
2020 402 402
2021 269 269

Device Problems MDRs with this Device Problem Events in those MDRs
Break 409 409
Microbial Contamination of Device 143 143
Adverse Event Without Identified Device or Use Problem 112 112
No Display/Image 69 69
Poor Quality Image 48 48
Material Protrusion/Extrusion 47 47
Fluid Leak 40 40
Mechanical Problem 34 34
Appropriate Term/Code Not Available 29 29
Leak/Splash 28 28
Device Reprocessing Problem 28 28
Material Puncture/Hole 18 18
Device Contamination with Chemical or Other Material 17 17
Material Deformation 17 17
Difficult to Remove 14 14
Defective Device 12 12
Fracture 11 11
Material Separation 10 10
Mechanical Jam 10 10
Material Split, Cut or Torn 10 10
Physical Resistance/Sticking 9 9
Material Twisted/Bent 9 9
Contamination /Decontamination Problem 9 9
Material Perforation 9 9
Material Fragmentation 9 9
Crack 9 9
Device Damaged Prior to Use 8 8
Tear, Rip or Hole in Device Packaging 8 8
Device Operates Differently Than Expected 8 8
Insufficient Information 8 8
Device Handling Problem 7 7
Use of Device Problem 7 7
Detachment Of Device Component 7 7
Display or Visual Feedback Problem 6 6
No Device Output 6 6
Defective Component 6 6
Device Displays Incorrect Message 6 6
Failure to Power Up 5 5
Peeled/Delaminated 5 5
Kinked 5 5
Entrapment of Device 5 5
Contamination 5 5
Bent 5 5
Unintended Movement 5 5
Optical Problem 5 5
Device Damaged by Another Device 4 4
Improper Device Output 4 4
Display Difficult to Read 4 4
Erratic or Intermittent Display 4 4
Material Frayed 4 4
Problem with Sterilization 4 4
Component Missing 4 4
Cut In Material 4 4
Retraction Problem 3 3
Material Too Rigid or Stiff 3 3
Hole In Material 3 3
Image Display Error/Artifact 3 3
Unsealed Device Packaging 3 3
Melted 3 3
Degraded 3 3
False Device Output 3 3
Device Dislodged or Dislocated 3 3
Detachment of Device or Device Component 3 3
Device Contamination With Biological Material 2 2
Dent in Material 2 2
Connection Problem 2 2
Difficult to Advance 2 2
Material Integrity Problem 2 2
Positioning Problem 2 2
Power Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unexpected Shutdown 2 2
Failure to Clean Adequately 2 2
Thermal Decomposition of Device 2 2
Corroded 2 2
Loose or Intermittent Connection 2 2
Labelling, Instructions for Use or Training Problem 2 2
Loss of Power 2 2
Blocked Connection 2 2
Fitting Problem 2 2
Out-Of-Box Failure 1 1
Obstruction of Flow 1 1
Deformation Due to Compressive Stress 1 1
Communication or Transmission Problem 1 1
Structural Problem 1 1
Failure to Advance 1 1
Aspiration Issue 1 1
Difficult To Position 1 1
Material Rupture 1 1
Sticking 1 1
Stretched 1 1
Unstable 1 1
Improper or Incorrect Procedure or Method 1 1
Product Quality Problem 1 1
Material Invagination 1 1
Fogging 1 1
Image Resolution Poor 1 1
Device Maintenance Issue 1 1
Nonstandard Device 1 1
Component Falling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 368 368
No Known Impact Or Consequence To Patient 246 246
No Clinical Signs, Symptoms or Conditions 210 210
No Patient Involvement 149 149
Injury 48 48
Unspecified Infection 41 41
Fever 26 26
No Code Available 14 14
Perforation 13 13
Foreign Body In Patient 12 12
Insufficient Information 11 11
Bacterial Infection 11 11
Laceration(s) 6 6
Device Embedded In Tissue or Plaque 6 6
No Information 5 5
Patient Problem/Medical Problem 5 5
Inflammation 5 5
Tissue Damage 5 5
Physical Entrapment 3 3
Hematuria 2 2
Urinary Tract Infection 2 2
Hemorrhage/Bleeding 2 2
Death 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Unspecified Kidney or Urinary Problem 2 2
Unspecified Blood or Lymphatic problem 1 1
Urethral Stenosis/Stricture 1 1
Edema 1 1
Hematoma 1 1
Abdominal Pain 1 1
Nausea 1 1
Internal Organ Perforation 1 1
Pain 1 1
Renal Failure 1 1
Sepsis 1 1
Septic Shock 1 1
Tachycardia 1 1
Uterine Perforation 1 1
Vomiting 1 1
Rupture 1 1
Excessive Tear Production 1 1
Stenosis 1 1
Blood Loss 1 1
Intraoperative Pain 1 1
Complaint, Ill-Defined 1 1
Increased Respiratory Rate 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Jul-20-2018
2 Pentax Medical Company II Jun-28-2016
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