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
AURIS HEALTH INC
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
1.  K221515  StoneSmart Connect Console, LithoVue Elite Single ...
2.  K241598  LithoVue Elite Single-Use Digital Flexible Uretero ...
3.  K252703  LithoVue Elite Single-Use Digital Flexible Uretero ...
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	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