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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
AMBU A/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
  1.  K233700  Avicenna Roboflex
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 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
HUNAN VATHIN MEDICAL INSTRUMENT CO.LTD
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOVISION, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
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 458 458
2024 572 572
2025 945 961

Device Problems MDRs with this Device Problem Events in those MDRs
Break 693 693
Failure to Clean Adequately 292 292
Microbial Contamination of Device 248 248
Adverse Event Without Identified Device or Use Problem 213 229
Device Reprocessing Problem 201 201
Detachment of Device or Device Component 186 186
Mechanical Problem 121 121
No Display/Image 105 105
Loss of or Failure to Bond 96 96
Material Split, Cut or Torn 88 88
Poor Quality Image 83 83
Peeled/Delaminated 75 75
Material Protrusion/Extrusion 64 64
Physical Resistance/Sticking 63 63
Optical Problem 56 56
Material Deformation 56 56
Contamination 55 55
Material Puncture/Hole 48 48
Corroded 46 46
Mechanical Jam 43 43
Material Separation 40 40
Fluid/Blood Leak 39 39
Material Twisted/Bent 38 38
Degraded 35 35
Appropriate Term/Code Not Available 31 31
Erratic or Intermittent Display 31 31
Crack 31 31
Leak/Splash 29 29
Scratched Material 29 29
Insufficient Information 27 27
Gas/Air Leak 26 26
Contamination /Decontamination Problem 26 26
Device Contamination with Chemical or Other Material 24 24
Display or Visual Feedback Problem 22 22
Positioning Failure 20 20
Defective Component 19 19
Material Integrity Problem 18 18
Device Displays Incorrect Message 17 17
Loose or Intermittent Connection 17 17
Component Missing 17 17
Defective Device 16 16
Unsealed Device Packaging 15 15
Residue After Decontamination 15 15
Difficult to Remove 14 14
Improper or Incorrect Procedure or Method 14 14
Material Fragmentation 14 14
Use of Device Problem 13 13
Unintended Movement 12 12
Fracture 11 11
Obstruction of Flow 11 11

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2296 2296
No Consequences Or Impact To Patient 220 220
Urinary Tract Infection 171 187
No Patient Involvement 89 89
Insufficient Information 76 76
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
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