TPLC - Total Product Life Cycle

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Device	ureteroscope and accessories, flexible/rigid
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	2
BOSTON SCIENTIFIC CORPORATION -
	SUBSTANTIALLY EQUIVALENT	1
CENTERPOINT SYSTEMS LLC
	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 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
SHANGHAI ANQING MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	558	558
Microbial Contamination of Device	236	236
Adverse Event Without Identified Device or Use Problem	202	202
Failure to Clean Adequately	188	188
Device Reprocessing Problem	147	147
Mechanical Problem	95	95
Detachment of Device or Device Component	77	77
No Display/Image	61	61
Peeled/Delaminated	61	61
Material Protrusion/Extrusion	59	59
Poor Quality Image	56	56
Material Split, Cut or Torn	54	54
Contamination	42	42
Fluid/Blood Leak	39	39
Material Twisted/Bent	34	34
Material Puncture/Hole	33	33
Physical Resistance/Sticking	33	33
Appropriate Term/Code Not Available	31	31
Scratched Material	26	26
Mechanical Jam	24	24
Crack	23	23
Device Contamination with Chemical or Other Material	23	23
Material Separation	23	23
Leak/Splash	23	23
Material Deformation	22	22
Corroded	22	22
Contamination /Decontamination Problem	21	21
Insufficient Information	19	19
Defective Component	16	16
Device Displays Incorrect Message	15	15
Optical Problem	14	14
Unsealed Device Packaging	14	14
Material Fragmentation	13	13
Defective Device	12	12
Use of Device Problem	11	11
Degraded	11	11
Loose or Intermittent Connection	11	11
Erratic or Intermittent Display	10	10
Unintended Movement	10	10
Difficult to Remove	10	10
Component Missing	9	9
Improper or Incorrect Procedure or Method	9	9
Material Integrity Problem	8	8
Melted	8	8
Problem with Sterilization	8	8
Display or Visual Feedback Problem	7	7
Device Damaged by Another Device	7	7
Material Perforation	7	7
Positioning Problem	6	6
Fracture	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1403	1403
No Consequences Or Impact To Patient	220	220
Urinary Tract Infection	166	166
No Patient Involvement	89	89
Fever	75	75
Unspecified Infection	73	73
Insufficient Information	49	49
No Known Impact Or Consequence To Patient	44	44
Pain	28	28
Sepsis	25	25
Unspecified Kidney or Urinary Problem	25	25
Foreign Body In Patient	22	22
Injury	21	21
Bacterial Infection	15	15
Hemorrhage/Bleeding	11	11
Laceration(s)	10	10
Hematuria	10	10
Perforation	9	9
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
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
Device Embedded In Tissue or Plaque	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
No Information	2	2
Renal Impairment	2	2
Swelling/ Edema	2	2
Disseminated Intravascular Coagulation (DIC)	2	2
Abscess	2	2
Kidney Infection	1	1
Patient Problem/Medical Problem	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	May-12-2022
4	Olympus Corporation of the Americas	II	Jun-13-2022