Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 endoscopic grasping/cutting instrument, non-powered
Definition To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.
Product CodeOCZ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 21 21
2021 20 20
2022 33 33
2023 25 25
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Break 46 46
Difficult to Open or Close 20 20
Adverse Event Without Identified Device or Use Problem 14 14
Material Fragmentation 10 10
Material Separation 8 8
Detachment of Device or Device Component 6 6
Difficult to Remove 5 5
Insufficient Information 4 4
Arcing 4 4
Activation, Positioning or Separation Problem 3 3
Mechanical Problem 3 3
Entrapment of Device 3 3
Material Twisted/Bent 3 3
Mechanics Altered 3 3
Flushing Problem 3 3
Temperature Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Physical Resistance/Sticking 2 2
Unintended Movement 2 2
Defective Device 2 2
Failure to Cut 2 2
Mechanical Jam 2 2
Leak/Splash 1 1
Activation Problem 1 1
Device Fell 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Integrity Problem 1 1
Unsealed Device Packaging 1 1
Device Damaged by Another Device 1 1
Sharp Edges 1 1
Packaging Problem 1 1
Material Deformation 1 1
Failure to Advance 1 1
Connection Problem 1 1
Product Quality Problem 1 1
Activation Failure 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 57 57
Insufficient Information 22 22
No Known Impact Or Consequence To Patient 14 14
Foreign Body In Patient 14 14
No Consequences Or Impact To Patient 7 7
No Code Available 5 5
Superficial (First Degree) Burn 4 4
Hemorrhage/Bleeding 4 4
Burn(s) 3 3
Laceration(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Abdominal Distention 2 2
Perforation 2 2
Device Embedded In Tissue or Plaque 2 2
Patient Problem/Medical Problem 1 1
Abdominal Pain 1 1
Death 1 1
Bowel Perforation 1 1
Blister 1 1
Pericardial Effusion 1 1
No Patient Involvement 1 1
Unspecified Kidney or Urinary Problem 1 1
Pain 1 1
Tissue Damage 1 1
Partial thickness (Second Degree) Burn 1 1
Granuloma 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hobbs Medical, Inc. II Oct-07-2022
2 Hobbs Medical, Inc. II Jul-15-2022
3 Shent USA, Inc. II Aug-06-2021
-
-