TPLC - Total Product Life Cycle

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Device	endoscopic access overtube, gastroenterology-urology
Regulation Description	Endoscope and accessories.
Definition	To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.
Product Code	FED
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANHUI HAPPINESS WORKSHOP MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
CALYXO, INC.
	SUBSTANTIALLY EQUIVALENT	1
CATHEGENIX (XIAMEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST CORP.
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH AMERICA
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEPTUNE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
	SUBSTANTIALLY EQUIVALENT - KIT	1
PRODEON MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SEPLOU (ZHUHAI) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN HUGEMED MEDICAL TECHNICAL DEVELOPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN TRIOUS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU BEYO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TROKAMED GMBH
	SUBSTANTIALLY EQUIVALENT	1
YOUCARE TECHNOLOGY CO.,LTD. (WUHAN)
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG YIGAO MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHUHAI PUSEN MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Peeled/Delaminated	65	65
Adverse Event Without Identified Device or Use Problem	64	64
Material Split, Cut or Torn	35	35
Device Contamination with Chemical or Other Material	20	20
Break	20	20
Unsealed Device Packaging	19	19
Material Integrity Problem	18	18
Difficult to Insert	16	16
Detachment of Device or Device Component	14	14
Flaked	9	9
Accessory Incompatible	9	9
Material Deformation	8	8
Material Fragmentation	8	8
Device Contaminated During Manufacture or Shipping	7	7
Tear, Rip or Hole in Device Packaging	7	7
Partial Blockage	7	7
Material Twisted/Bent	7	7
Difficult to Advance	7	7
Insufficient Information	6	6
Nonstandard Device	5	5
Device-Device Incompatibility	4	4
Material Separation	4	4
Material Too Rigid or Stiff	4	4
Defective Device	4	4
Deformation Due to Compressive Stress	3	3
Material Protrusion/Extrusion	3	3
Inflation Problem	3	3
Use of Device Problem	3	3
Unraveled Material	3	3
Inability to Irrigate	3	3
Complete Blockage	3	3
Contamination	2	2
Difficult to Remove	2	2
Separation Failure	2	2
Shipping Damage or Problem	2	2
Device Damaged Prior to Use	2	2
Restricted Flow rate	2	2
Component Misassembled	2	2
Component or Accessory Incompatibility	2	2
Material Frayed	2	2
Disconnection	2	2
Defective Component	1	1
Scratched Material	1	1
Patient Device Interaction Problem	1	1
Unintended Deflation	1	1
Material Puncture/Hole	1	1
Material Disintegration	1	1
Decrease in Suction	1	1
Device Damaged by Another Device	1	1
Suction Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	259	259
Perforation	25	25
Hemorrhage/Bleeding	15	15
Insufficient Information	13	13
Foreign Body In Patient	10	10
Sepsis	9	9
Bowel Perforation	8	8
Low Blood Pressure/ Hypotension	7	7
Cardiac Arrest	6	6
Hematuria	5	5
Respiratory Failure	4	4
Inflammation	4	4
Unspecified Tissue Injury	4	4
Pain	4	4
Fever	4	4
Disseminated Intravascular Coagulation (DIC)	4	4
Septic Shock	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Information	3	3
Ischemia	3	3
Rupture	3	3
Ascites	2	2
Hypoxia	2	2
Aneurysm	2	2
Tachycardia	2	2
Extravasation	2	2
Shock	2	2
Unspecified Kidney or Urinary Problem	2	2
Laceration(s)	2	2
Urinary Retention	2	2
Thrombosis/Thrombus	2	2
Peritonitis	2	2
Atrial Fibrillation	2	2
Increased Intra-Peritoneal Volume (IIPV)	2	2
Vascular Dissection	2	2
Necrosis	2	2
Perforation of Esophagus	2	2
Nausea	2	2
Abdominal Pain	2	2
Discomfort	1	1
No Patient Involvement	1	1
Vomiting	1	1
Chills	1	1
Easy Bruising	1	1
Hematoma	1	1
No Consequences Or Impact To Patient	1	1
Erosion	1	1
Gastrointestinal Hemorrhage	1	1
Constipation	1	1
Pneumothorax	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Calyxo, Inc.	I	Mar-21-2025
2	Olympus Corporation of the Americas	II	Sep-03-2021
3	Trokamed GmbH	I	Jan-10-2025