Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
AMBUA/S
  SUBSTANTIALLY EQUIVALENT 2
AURIS HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION -
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONTRA HEALTHCARE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DYNE MEDICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELMED ELEKTRONIK VE MEDIKAL SANAYI VE TICARET ANONIM SIRKETI
  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 2
HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOVISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO.KG
  SUBSTANTIALLY EQUIVALENT 4
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER &IBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
OPCOM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OTU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEPLOU (ZHUHAI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SG ENDOSCOPY PTE, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN BESDATA TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SANPING IMAGE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 402 402
2021 325 325
2022 455 455
2023 458 460
2024 572 572
2025 1071 1087

Device Problems MDRs with this Device Problem Events in those MDRs
Break 709 710
Failure to Clean Adequately 304 304
Microbial Contamination of Device 249 249
Adverse Event Without Identified Device or Use Problem 213 230
Device Reprocessing Problem 209 209
Detachment of Device or Device Component 206 206
Mechanical Problem 122 122
No Display/Image 114 114
Loss of or Failure to Bond 106 106
Material Split, Cut or Torn 96 96
Poor Quality Image 85 85
Peeled/Delaminated 79 79
Physical Resistance/Sticking 71 71
Material Protrusion/Extrusion 64 64
Material Deformation 61 61
Contamination 56 56
Optical Problem 56 56
Corroded 53 53
Mechanical Jam 50 50
Material Puncture/Hole 50 50
Degraded 45 45
Material Separation 42 42
Fluid/Blood Leak 39 39
Material Twisted/Bent 38 38
Appropriate Term/Code Not Available 31 31
Erratic or Intermittent Display 31 31
Crack 31 31
Leak/Splash 30 30
Scratched Material 29 29
Gas/Air Leak 28 28
Insufficient Information 28 28
Contamination /Decontamination Problem 27 27
Display or Visual Feedback Problem 27 27
Device Contamination with Chemical or Other Material 24 24
Positioning Failure 21 21
Defective Component 19 19
Residue After Decontamination 18 18
Material Integrity Problem 18 18
Defective Device 17 17
Loose or Intermittent Connection 17 17
Component Missing 17 17
Device Displays Incorrect Message 17 17
Unsealed Device Packaging 15 15
Material Fragmentation 15 15
Unintended Movement 14 14
Difficult to Remove 14 14
Improper or Incorrect Procedure or Method 14 14
Use of Device Problem 13 13
Fracture 11 11
Melted 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2419 2420
No Consequences Or Impact To Patient 220 220
Urinary Tract Infection 171 187
No Patient Involvement 89 89
Insufficient Information 80 80
Unspecified Infection 75 91
Fever 75 75
No Known Impact Or Consequence To Patient 44 44
Sepsis 34 50
Pain 30 30
Foreign Body In Patient 28 28
Unspecified Kidney or Urinary Problem 27 27
Injury 21 21
Hemorrhage/Bleeding 15 15
Bacterial Infection 15 15
Laceration(s) 12 12
Hematuria 11 11
Perforation 10 10
Septic Shock 9 9
Urinary Frequency 8 8
Renal Failure 8 8
Unspecified Tissue Injury 7 7
Inflammation 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Device Embedded In Tissue or Plaque 5 5
Obstruction/Occlusion 5 5
Urethral Stenosis/Stricture 5 5
Nausea 5 5
Urinary Retention 5 5
Chills 4 4
Hematoma 3 3
Internal Organ Perforation 3 3
Abrasion 3 3
Rupture 3 3
Physical Entrapment 3 3
No Code Available 3 3
Discomfort 3 3
Death 2 2
Swelling/ Edema 2 2
Stenosis 2 2
Abscess 2 2
Drug Resistant Bacterial Infection 2 2
Renal Impairment 2 2
Vomiting 2 2
Hepatitis 2 2
Burn(s) 2 2
Bowel Burn 2 2
No Information 2 2
Thrombosis/Thrombus 1 1
Chest Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AURIS HEALTH INC II Oct-10-2024
2 Aizu Olympus Co., Ltd. II Nov-17-2023
3 Karl Storz Endoscopy II Jan-30-2025
4 Karl Storz Endoscopy II May-12-2022
5 Olympus Corporation of the Americas II Jun-13-2022
-
-