• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device hemostatic metal clip for the gi tract
Definition Clip placement within the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis for mucosal/sub-mucosal defects, bleeding ulcers, arteries, polyps, diverticula in the colon, prophylactic clipping, anchoring feeding tubes, supplemental closure method of luminal perforations.
Product CodePKL
Regulation Number 876.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
ANREI MEDICAL (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
APOLLO ENDOSURGERY, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING ZKSK TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
FINEMEDIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INCORE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
MIRCO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
OVESCO ENDOSCOPY AG
  SUBSTANTIALLY EQUIVALENT 2
PROMISEMED HANGZHOU MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 698 698
2020 504 504
2021 668 668
2022 522 522
2023 863 863
2024 505 505

Device Problems MDRs with this Device Problem Events in those MDRs
Activation, Positioning or Separation Problem 2025 2025
Difficult to Open or Close 482 482
Break 265 265
Material Separation 251 251
Premature Activation 250 250
Adverse Event Without Identified Device or Use Problem 229 229
Separation Failure 229 229
Failure to Fire 228 228
Premature Separation 162 162
Detachment of Device or Device Component 132 132
Use of Device Problem 121 121
Material Deformation 86 86
Human-Device Interface Problem 78 78
Material Twisted/Bent 68 68
Positioning Failure 66 66
Entrapment of Device 63 63
Difficult or Delayed Separation 60 60
Device Fell 36 36
Difficult to Remove 35 35
Improper or Incorrect Procedure or Method 32 32
Failure to Advance 30 30
Mechanical Problem 29 29
Activation Problem 26 26
Defective Device 24 24
Device Dislodged or Dislocated 20 20
Mechanical Jam 19 19
Problem with Sterilization 18 18
Difficult to Advance 16 16
Failure to Eject 16 16
Physical Resistance/Sticking 16 16
Migration 15 15
Misfire 15 15
Material Fragmentation 13 13
Firing Problem 13 13
Insufficient Information 11 11
Peeled/Delaminated 11 11
Unraveled Material 9 9
Nonstandard Device 8 8
Material Protrusion/Extrusion 8 8
Material Integrity Problem 7 7
Failure to Form Staple 7 7
Failure to Disconnect 7 7
Failure to Deliver 7 7
Failure to Discharge 7 7
Appropriate Term/Code Not Available 7 7
Activation Failure 7 7
Unintended Movement 7 7
Separation Problem 6 6
Device Reprocessing Problem 6 6
Defective Component 5 5
Off-Label Use 5 5
Component Missing 4 4
Product Quality Problem 3 3
Self-Activation or Keying 3 3
Contamination 3 3
Loss of or Failure to Bond 3 3
Difficult or Delayed Positioning 3 3
Unintended System Motion 3 3
Connection Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Mechanics Altered 3 3
Therapeutic or Diagnostic Output Failure 3 3
Failure to Clean Adequately 3 3
Ejection Problem 2 2
Packaging Problem 2 2
Positioning Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Difficult or Delayed Activation 2 2
Migration or Expulsion of Device 2 2
Fracture 2 2
Unsealed Device Packaging 2 2
Device Slipped 2 2
Particulates 1 1
Device Difficult to Setup or Prepare 1 1
Loose or Intermittent Connection 1 1
No Device Output 1 1
Disconnection 1 1
Crack 1 1
Degraded 1 1
Component(s), broken 1 1
Structural Problem 1 1
Malposition of Device 1 1
Deformation Due to Compressive Stress 1 1
Capturing Problem 1 1
Component or Accessory Incompatibility 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Expulsion 1 1
Inadequate User Interface 1 1
Scratched Material 1 1
Output Problem 1 1
Noise, Audible 1 1
Non Reproducible Results 1 1
Sharp Edges 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2208 2208
No Consequences Or Impact To Patient 877 877
No Known Impact Or Consequence To Patient 249 249
Hemorrhage/Bleeding 151 151
Insufficient Information 75 75
Foreign Body In Patient 66 66
Gastrointestinal Hemorrhage 58 58
Perforation 39 39
No Code Available 18 18
Device Embedded In Tissue or Plaque 16 16
Unspecified Tissue Injury 15 15
Bowel Perforation 14 14
Tissue Damage 14 14
Blood Loss 12 12
No Patient Involvement 11 11
Laceration(s) 10 10
Abdominal Pain 8 8
Peritonitis 7 7
Injury 6 6
Pain 5 5
Failure of Implant 5 5
Hematoma 5 5
Hemostasis 4 4
Ulcer 4 4
Unspecified Respiratory Problem 4 4
Pancreatitis 4 4
Laceration(s) of Esophagus 3 3
Obstruction/Occlusion 3 3
Swelling/ Edema 3 3
Discomfort 3 3
Vomiting 3 3
Stenosis 3 3
Internal Organ Perforation 3 3
Hyperemia 3 3
Inflammation 3 3
Death 3 3
Fever 2 2
Aspiration/Inhalation 2 2
Chest Pain 2 2
Abrasion 2 2
Nausea 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hematemesis 2 2
No Information 2 2
Melena 1 1
Increased Intra-Peritoneal Volume (IIPV) 1 1
Needle Stick/Puncture 1 1
Perforation of Esophagus 1 1
Fluid Discharge 1 1
Myocardial Infarction 1 1
Urinary Tract Infection 1 1
Pneumonia 1 1
Septic Shock 1 1
Therapeutic Response, Decreased 1 1
Abscess 1 1
Adhesion(s) 1 1
Fistula 1 1
Unspecified Infection 1 1
Hypersensitivity/Allergic reaction 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Jun-21-2023
2 US Endoscopy Group Inc II Mar-13-2019
-
-