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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Difficult to Open or Close 20 20
Adverse Event Without Identified Device or Use Problem 14 14
Material Separation 8 8
Detachment of Device or Device Component 6 6
Material Fragmentation 5 5
Difficult to Remove 5 5
Arcing 4 4
Activation, Positioning or Separation Problem 3 3
Mechanical Problem 3 3
Entrapment of Device 3 3
Flushing Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Temperature Problem 3 3
Material Twisted/Bent 3 3
Mechanics Altered 3 3
Insufficient Information 3 3
Physical Resistance/Sticking 2 2
Failure to Cut 2 2
Defective Device 2 2
Connection Problem 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Leak/Splash 1 1
Sharp Edges 1 1
Device Fell 1 1
Activation Problem 1 1
Activation Failure 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Device Damaged by Another Device 1 1
Material Deformation 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 47 47
Insufficient Information 22 22
No Known Impact Or Consequence To Patient 14 14
Foreign Body In Patient 12 12
No Consequences Or Impact To Patient 7 7
No Code Available 5 5
Hemorrhage/Bleeding 4 4
Burn(s) 3 3
Superficial (First Degree) Burn 3 3
Perforation 2 2
Abdominal Distention 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Device Embedded In Tissue or Plaque 2 2
Unspecified Kidney or Urinary Problem 1 1
Blister 1 1
No Patient Involvement 1 1
Bowel Perforation 1 1
Death 1 1
Granuloma 1 1
Pain 1 1
Tissue Damage 1 1
Abdominal Pain 1 1
Patient Problem/Medical Problem 1 1
Partial thickness (Second Degree) Burn 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
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