TPLC - Total Product Life Cycle

• 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 Code: FGB
• Regulation Number: 876.1500
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	2
ANHUI HAPPINESS WORKSHOP INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
AURIS HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
BOSTON SCIENTIFIC CORPORATION -
	SUBSTANTIALLY EQUIVALENT	1
CALYXO, INC.
	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	2
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
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	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
SHENZHEN SANPING IMAGE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
ZHEJIANG GEYI MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	325	325
2022	455	455
2023	458	460
2024	572	572
2025	1320	1336
2026	1379	1379

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	724	725
Detachment of Device or Device Component	613	613
Failure to Clean Adequately	420	420
Loss of or Failure to Bond	371	371
Device Reprocessing Problem	250	250
Microbial Contamination of Device	199	199
Peeled/Delaminated	168	168
Corroded	160	160
Adverse Event Without Identified Device or Use Problem	156	173
No Display/Image	141	141
Material Split, Cut or Torn	135	135
Mechanical Problem	122	122
Material Deformation	112	112
Physical Resistance/Sticking	110	110
Degraded	108	108
Poor Quality Image	90	90
Mechanical Jam	83	83
Contamination	76	76
Material Separation	76	76
Material Protrusion/Extrusion	75	75
Erratic or Intermittent Display	65	65
Optical Problem	65	65
Material Puncture/Hole	52	52
Material Fragmentation	51	51
Display or Visual Feedback Problem	44	44
Positioning Failure	42	42
Contamination /Decontamination Problem	39	39
Crack	39	39
Residue After Decontamination	38	38
Scratched Material	35	35
Gas/Air Leak	34	34
Insufficient Information	33	33
Material Twisted/Bent	32	32
Leak/Splash	26	26
Material Integrity Problem	24	24
Loose or Intermittent Connection	22	22
Defective Component	22	22
Unintended Movement	20	20
Component Missing	20	20
Difficult to Remove	20	20
Device Contamination with Chemical or Other Material	19	19
Output Problem	18	18
Positioning Problem	18	18
Device Displays Incorrect Message	17	17
Fracture	17	17
Obstruction of Flow	17	17
Optical Distortion	17	17
Sharp Edges	16	16
Appropriate Term/Code Not Available	16	16
Unsealed Device Packaging	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4002	4003
Urinary Tract Infection	176	192
Insufficient Information	100	100
Fever	56	56
Unspecified Infection	42	58
Sepsis	37	53
No Consequences Or Impact To Patient	36	36
Pain	32	32
Unspecified Kidney or Urinary Problem	27	27
Foreign Body In Patient	27	27
Bacterial Infection	17	17
Hemorrhage/Bleeding	15	15
Unspecified Tissue Injury	14	14
Hematuria	12	12
Laceration(s)	12	12
Perforation	10	10
Obstruction/Occlusion	9	9
Septic Shock	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Urinary Frequency	8	8
Renal Failure	8	8
Nausea	5	5
Urethral Stenosis/Stricture	5	5
No Patient Involvement	5	5
Urinary Retention	5	5
Chills	4	4
Device Embedded In Tissue or Plaque	3	3
Internal Organ Perforation	3	3
Hematoma	3	3
Inflammation	3	3
Abrasion	3	3
Rupture	3	3
Discomfort	3	3
Swelling/ Edema	2	2
Stenosis	2	2
Physical Entrapment	2	2
Abscess	2	2
Renal Impairment	2	2
Vomiting	2	2
Chest Pain	2	2
Hepatitis	2	2
Burn(s)	2	2
Bowel Burn	2	2
Drug Resistant Bacterial Infection	2	2
Abdominal Pain	2	2
Thrombosis/Thrombus	1	1
Pleural Effusion	1	1
Unspecified Blood or Lymphatic problem	1	1
No Known Impact Or Consequence To Patient	1	1
Device Overstimulation of Tissue	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