TPLC - Total Product Life Cycle

• 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
DORNIER MEDTECH AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
H&A MUI ENTERPRISES, INC.
	SUBSTANTIALLY EQUIVALENT	1
HUNAN VATHIN MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
KALERA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MACROLUX MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
1.  K250452  CoralWell™ Single-use Ureteral Access Sheath (NS-0 ...
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
WELL LEAD MEDICAL CO., LTD.
	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

MDR Year	MDR Reports	MDR Events
2020	33	33
2021	55	55
2022	36	36
2023	53	53
2024	64	64
2025	117	117

Device Problems	MDRs with this Device Problem	Events in those MDRs
Peeled/Delaminated	63	63
Adverse Event Without Identified Device or Use Problem	58	58
Material Split, Cut or Torn	33	33
Break	22	22
Material Integrity Problem	22	22
Device Contamination with Chemical or Other Material	20	20
Unsealed Device Packaging	19	19
Difficult to Insert	17	17
Detachment of Device or Device Component	12	12
Flaked	9	9
Accessory Incompatible	9	9
Tear, Rip or Hole in Device Packaging	8	8
Partial Blockage	7	7
Material Twisted/Bent	7	7
Difficult to Advance	7	7
Material Fragmentation	7	7
Device Contaminated During Manufacture or Shipping	6	6
Material Deformation	6	6
Insufficient Information	6	6
Nonstandard Device	5	5
Complete Blockage	5	5
Material Frayed	4	4
Material Separation	4	4
Inflation Problem	4	4
Material Too Rigid or Stiff	4	4
Defective Device	4	4
Difficult to Remove	4	4
Deformation Due to Compressive Stress	3	3
Device-Device Incompatibility	3	3
Material Protrusion/Extrusion	3	3
Inability to Irrigate	3	3
Use of Device Problem	3	3
Unraveled Material	3	3
Component Misassembled	2	2
Packaging Problem	2	2
Shipping Damage or Problem	2	2
Contamination /Decontamination Problem	2	2
Contamination	2	2
Separation Failure	2	2
Device Damaged Prior to Use	2	2
Restricted Flow rate	2	2
Crack	2	2
Component or Accessory Incompatibility	2	2
Disconnection	2	2
Scratched Material	1	1
Patient Device Interaction Problem	1	1
Defective Component	1	1
Unintended Deflation	1	1
Device Difficult to Setup or Prepare	1	1
Material Puncture/Hole	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	243	243
No Consequences Or Impact To Patient	21	21
Perforation	20	20
Hemorrhage/Bleeding	15	15
Insufficient Information	14	14
Sepsis	9	9
Foreign Body In Patient	9	9
Bowel Perforation	8	8
Low Blood Pressure/ Hypotension	7	7
Cardiac Arrest	6	6
No Known Impact Or Consequence To Patient	6	6
Hematuria	5	5
Respiratory Failure	4	4
Pain	4	4
Disseminated Intravascular Coagulation (DIC)	4	4
No Information	4	4
No Patient Involvement	4	4
Inflammation	4	4
Fever	4	4
Septic Shock	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Ischemia	3	3
Unspecified Tissue Injury	3	3
Rupture	3	3
Tachycardia	2	2
Shock	2	2
Extravasation	2	2
Unspecified Kidney or Urinary Problem	2	2
Laceration(s)	2	2
Aneurysm	2	2
Urinary Retention	2	2
Thrombosis/Thrombus	2	2
Hypoxia	2	2
Peritonitis	2	2
Atrial Fibrillation	2	2
Ascites	2	2
Increased Intra-Peritoneal Volume (IIPV)	2	2
Vascular Dissection	2	2
Perforation of Esophagus	2	2
Necrosis	2	2
Nausea	2	2
Abdominal Pain	2	2
Tissue Damage	1	1
Erosion	1	1
Constipation	1	1
Urinary Tract Infection	1	1
Discomfort	1	1
Vomiting	1	1
Injury	1	1
Chills	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boddingtons Plastics Ltd	II	Apr-16-2020
2	Calyxo, Inc.	I	Mar-21-2025
3	Olympus Corporation of the Americas	II	Sep-03-2021
4	Trokamed GmbH	I	Jan-10-2025