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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
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
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 232 232

Device Problems MDRs with this Device Problem Events in those MDRs
Break 394 394
Microbial Contamination of Device 141 141
Adverse Event Without Identified Device or Use Problem 112 112
No Display/Image 67 67
Poor Quality Image 47 47
Material Protrusion/Extrusion 46 46
Fluid Leak 40 40
Mechanical Problem 31 31
Appropriate Term/Code Not Available 28 28
Leak/Splash 28 28
Device Reprocessing Problem 25 25
Material Puncture/Hole 18 18
Material Deformation 17 17
Device Contamination with Chemical or Other Material 14 14
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
Material Twisted/Bent 9 9
Crack 9 9
Physical Resistance/Sticking 9 9
Contamination /Decontamination Problem 9 9
Tear, Rip or Hole in Device Packaging 8 8
Device Damaged Prior to Use 8 8
Material Fragmentation 8 8
Material Perforation 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
Device Displays Incorrect Message 6 6
No Device Output 6 6
Display or Visual Feedback Problem 6 6
Failure to Power Up 5 5
Bent 5 5
Kinked 5 5
Peeled/Delaminated 5 5
Contamination 5 5
Entrapment of Device 5 5
Optical Problem 5 5
Improper Device Output 4 4
Material Frayed 4 4
Display Difficult to Read 4 4
Erratic or Intermittent Display 4 4
Defective Component 4 4
Problem with Sterilization 4 4
Cut In Material 4 4
Component Missing 4 4
Device Damaged by Another Device 4 4
Device Dislodged or Dislocated 3 3
Retraction Problem 3 3
Material Too Rigid or Stiff 3 3
False Device Output 3 3
Degraded 3 3
Unsealed Device Packaging 3 3
Melted 3 3
Hole In Material 3 3
Image Display Error/Artifact 3 3
Loose or Intermittent Connection 2 2
Corroded 2 2
Fitting Problem 2 2
Connection Problem 2 2
Device Contamination With Biological Material 2 2
Dent in Material 2 2
Material Integrity Problem 2 2
Power Problem 2 2
Unintended Movement 2 2
Failure to Clean Adequately 2 2
Labelling, Instructions for Use or Training Problem 2 2
Loss of Power 2 2
Therapeutic or Diagnostic Output Failure 2 2
Detachment of Device or Device Component 2 2
Blocked Connection 2 2
Unexpected Shutdown 2 2
Deformation Due to Compressive Stress 1 1
Communication or Transmission Problem 1 1
Device Operational Issue 1 1
Output Problem 1 1
Difficult to Open or Close 1 1
Stretched 1 1
Out-Of-Box Failure 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Material Invagination 1 1
Nonstandard Device 1 1
Difficult To Position 1 1
Positioning Failure 1 1
Fogging 1 1
Sharp Edges 1 1
Positioning Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Distortion 1 1
Difficult to Advance 1 1
Aspiration Issue 1 1
Failure to Advance 1 1
Product Quality Problem 1 1
Material Rupture 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 175 175
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
Bacterial Infection 11 11
Insufficient Information 9 9
Laceration(s) 6 6
Device Embedded In Tissue or Plaque 6 6
No Information 5 5
Patient Problem/Medical Problem 5 5
Tissue Damage 5 5
Inflammation 5 5
Physical Entrapment 3 3
Hematuria 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Urinary Tract Infection 2 2
Death 2 2
Hemorrhage/Bleeding 2 2
Unspecified Kidney or Urinary Problem 2 2
Unspecified Blood or Lymphatic problem 1 1
Urethral Stenosis/Stricture 1 1
Abdominal Pain 1 1
Edema 1 1
Nausea 1 1
Internal Organ Perforation 1 1
Pain 1 1
Tachycardia 1 1
Uterine Perforation 1 1
Vomiting 1 1
Stenosis 1 1
Complaint, Ill-Defined 1 1
Increased Respiratory Rate 1 1
Blood Loss 1 1
Intraoperative Pain 1 1
Renal Failure 1 1
Sepsis 1 1
Septic Shock 1 1
Hematoma 1 1
Rupture 1 1
Excessive Tear Production 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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