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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 2
BOSTON SCIENTIFIC CORPORATION -
  SUBSTANTIALLY EQUIVALENT 1
CENTERPOINT SYSTEMS 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 1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOVISION, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  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
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
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
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 574 574
2025 148 148

Device Problems MDRs with this Device Problem Events in those MDRs
Break 589 589
Microbial Contamination of Device 241 241
Adverse Event Without Identified Device or Use Problem 205 205
Failure to Clean Adequately 204 204
Device Reprocessing Problem 158 158
Mechanical Problem 98 98
Detachment of Device or Device Component 85 85
No Display/Image 63 63
Peeled/Delaminated 62 62
Material Split, Cut or Torn 62 62
Poor Quality Image 61 61
Material Protrusion/Extrusion 59 59
Contamination 43 43
Fluid/Blood Leak 39 39
Material Puncture/Hole 38 38
Physical Resistance/Sticking 37 37
Material Twisted/Bent 34 34
Mechanical Jam 31 31
Appropriate Term/Code Not Available 31 31
Material Deformation 28 28
Scratched Material 26 26
Optical Problem 25 25
Material Separation 25 25
Leak/Splash 25 25
Crack 25 25
Corroded 23 23
Device Contamination with Chemical or Other Material 23 23
Contamination /Decontamination Problem 21 21
Insufficient Information 19 19
Defective Component 16 16
Device Displays Incorrect Message 15 15
Loose or Intermittent Connection 15 15
Material Fragmentation 14 14
Degraded 14 14
Unsealed Device Packaging 14 14
Erratic or Intermittent Display 13 13
Difficult to Remove 12 12
Defective Device 12 12
Use of Device Problem 11 11
Unintended Movement 10 10
Material Integrity Problem 9 9
Component Missing 9 9
Improper or Incorrect Procedure or Method 9 9
Display or Visual Feedback Problem 9 9
Melted 8 8
Material Perforation 8 8
Problem with Sterilization 8 8
Positioning Failure 7 7
Device Damaged by Another Device 7 7
Positioning Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1537 1537
No Consequences Or Impact To Patient 220 220
Urinary Tract Infection 169 169
No Patient Involvement 89 89
Fever 75 75
Unspecified Infection 73 73
Insufficient Information 57 57
No Known Impact Or Consequence To Patient 44 44
Pain 29 29
Sepsis 27 27
Unspecified Kidney or Urinary Problem 25 25
Foreign Body In Patient 24 24
Injury 21 21
Bacterial Infection 15 15
Hemorrhage/Bleeding 12 12
Laceration(s) 11 11
Hematuria 11 11
Perforation 10 10
Urinary Frequency 8 8
Septic Shock 8 8
Renal Failure 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Inflammation 6 6
Nausea 5 5
Urinary Retention 5 5
Urethral Stenosis/Stricture 5 5
Obstruction/Occlusion 5 5
Device Embedded In Tissue or Plaque 4 4
Unspecified Tissue Injury 4 4
Chills 4 4
Rupture 3 3
Abrasion 3 3
Hematoma 3 3
Discomfort 3 3
Physical Entrapment 3 3
No Code Available 3 3
Bowel Burn 2 2
Low Blood Pressure/ Hypotension 2 2
Hepatitis 2 2
Burn(s) 2 2
Internal Organ Perforation 2 2
Death 2 2
Vomiting 2 2
Drug Resistant Bacterial Infection 2 2
No Information 2 2
Renal Impairment 2 2
Disseminated Intravascular Coagulation (DIC) 2 2
Abscess 2 2
Swelling/ Edema 2 2
Kidney Infection 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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