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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
KARL STORZ ENDOSCOPY AMERICA
  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 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  1.  K211347  Uretero1 Ureteroscope System
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 325 325

Device Problems MDRs with this Device Problem Events in those MDRs
Break 437 437
Microbial Contamination of Device 146 146
Adverse Event Without Identified Device or Use Problem 113 113
No Display/Image 69 69
Poor Quality Image 48 48
Material Protrusion/Extrusion 48 48
Fluid Leak 41 41
Mechanical Problem 35 35
Appropriate Term/Code Not Available 30 30
Device Reprocessing Problem 29 29
Leak/Splash 28 28
Material Puncture/Hole 20 20
Device Contamination with Chemical or Other Material 20 20
Material Deformation 17 17
Difficult to Remove 15 15
Defective Device 14 14
Contamination /Decontamination Problem 12 12
Material Split, Cut or Torn 11 11
Mechanical Jam 11 11
Fracture 11 11
Material Fragmentation 10 10
Material Separation 10 10
Material Perforation 9 9
Crack 9 9
Material Twisted/Bent 9 9
Physical Resistance/Sticking 9 9
Insufficient Information 9 9
Unintended Movement 8 8
Device Operates Differently Than Expected 8 8
Device Damaged Prior to Use 8 8
Defective Component 8 8
Tear, Rip or Hole in Device Packaging 8 8
Use of Device Problem 7 7
Detachment Of Device Component 7 7
Device Handling Problem 7 7
Display or Visual Feedback Problem 6 6
No Device Output 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
Failure to Clean Adequately 5 5
Optical Problem 5 5
Detachment of Device or Device Component 4 4
Improper Device Output 4 4
Device Damaged by Another Device 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
Difficult to Advance 3 3
Device Dislodged or Dislocated 3 3
Material Integrity Problem 2 2
Device Contamination With Biological Material 2 2
Dent in Material 2 2
Connection Problem 2 2
Positioning Problem 2 2
Power Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unexpected Shutdown 2 2
Positioning Failure 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
Residue After Decontamination 1 1
Deformation Due to Compressive Stress 1 1
Aspiration Issue 1 1
Structural Problem 1 1
Failure to Advance 1 1
Obstruction of Flow 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 368 368
No Clinical Signs, Symptoms or Conditions 261 261
No Known Impact Or Consequence To Patient 246 246
No Patient Involvement 149 149
Injury 48 48
Unspecified Infection 41 41
Fever 26 26
No Code Available 14 14
Insufficient Information 14 14
Foreign Body In Patient 13 13
Perforation 13 13
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
Unspecified Kidney or Urinary Problem 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hematuria 2 2
Urinary Tract Infection 2 2
Hemorrhage/Bleeding 2 2
Death 2 2
Sepsis 2 2
Septic Shock 1 1
Tachycardia 1 1
Renal Failure 1 1
Nausea 1 1
Internal Organ Perforation 1 1
Pain 1 1
Edema 1 1
Hematoma 1 1
Abdominal Pain 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
Unspecified Blood or Lymphatic problem 1 1
Urethral Stenosis/Stricture 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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