TPLC - Total Product Life Cycle

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Device	endoscopic access overtube, gastroenterology-urology
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
BODDINGTONS PLASTICS LTD
	SUBSTANTIALLY EQUIVALENT	1
CALYXO, INC.
	SUBSTANTIALLY EQUIVALENT	1
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DORNIER MEDTECH AMERICA INC
	SUBSTANTIALLY EQUIVALENT	1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
H&A MUI ENTERPRISES INC.
	SUBSTANTIALLY EQUIVALENT	1
KALERA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NEPTUNE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
	SUBSTANTIALLY EQUIVALENT - KIT	1
SUMITOMO BAKELITE 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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Peeled/Delaminated	38	38
Material Split, Cut or Torn	28	28
Adverse Event Without Identified Device or Use Problem	24	24
Material Integrity Problem	19	19
Break	18	18
Unsealed Device Packaging	12	12
Flaked	11	11
Difficult to Insert	10	10
Difficult to Advance	9	9
Device Contamination with Chemical or Other Material	9	9
Detachment of Device or Device Component	8	8
Misassembled	7	7
Tear, Rip or Hole in Device Packaging	7	7
Device Contaminated During Manufacture or Shipping	6	6
Accessory Incompatible	5	5
Material Separation	5	5
Complete Blockage	5	5
Material Deformation	5	5
Material Frayed	4	4
Defective Device	4	4
Material Fragmentation	4	4
Material Too Rigid or Stiff	4	4
Inflation Problem	4	4
Device-Device Incompatibility	3	3
Difficult to Remove	3	3
Unraveled Material	3	3
Insufficient Information	3	3
Material Twisted/Bent	3	3
Partial Blockage	3	3
Inability to Irrigate	3	3
Crack	2	2
Restricted Flow rate	2	2
Device Damaged Prior to Use	2	2
Nonstandard Device	2	2
Packaging Problem	2	2
Material Protrusion/Extrusion	2	2
Separation Failure	2	2
Shipping Damage or Problem	2	2
Contamination	2	2
Scratched Material	2	2
Contamination /Decontamination Problem	2	2
Disconnection	2	2
Unintended Deflation	1	1
Material Disintegration	1	1
Patient-Device Incompatibility	1	1
Material Puncture/Hole	1	1
Positioning Problem	1	1
Premature Separation	1	1
Improper Chemical Reaction	1	1
Suction Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	143	143
No Consequences Or Impact To Patient	41	41
No Known Impact Or Consequence To Patient	21	21
Insufficient Information	12	12
Perforation	9	9
Foreign Body In Patient	9	9
Hemorrhage/Bleeding	7	7
No Patient Involvement	5	5
Respiratory Failure	4	4
No Information	4	4
Inflammation	4	4
Cardiac Arrest	4	4
Unspecified Tissue Injury	3	3
Laceration(s)	3	3
Septic Shock	3	3
Injury	3	3
Ascites	2	2
Tissue Damage	2	2
Hypoxia	2	2
Aneurysm	2	2
Unspecified Kidney or Urinary Problem	2	2
Disseminated Intravascular Coagulation (DIC)	2	2
Thrombosis/Thrombus	2	2
Rupture	2	2
Ischemia	2	2
Increased Intra-Peritoneal Volume (IIPV)	2	2
Vascular Dissection	2	2
Hematuria	2	2
Perforation of Esophagus	2	2
Necrosis	2	2
Fever	1	1
Peritonitis	1	1
Easy Bruising	1	1
Blood Loss	1	1
Laceration(s) of Esophagus	1	1
Urinary Retention	1	1
Discomfort	1	1
Pain	1	1
Shock	1	1
Gastrointestinal Hemorrhage	1	1
No Code Available	1	1
Erosion	1	1
Pneumothorax	1	1
Death	1	1
Patient Problem/Medical Problem	1	1
Internal Organ Perforation	1	1
Air Embolism	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boddingtons Plastics Ltd	II	Apr-16-2020
2	Olympus Corporation of the Americas	II	Sep-03-2021