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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
Mechanical Problem 3 3
Insufficient Information 3 3
Flushing Problem 3 3
Temperature Problem 3 3
Mechanics Altered 3 3
Entrapment of Device 3 3
Material Twisted/Bent 3 3
Improper or Incorrect Procedure or Method 3 3
Activation, Positioning or Separation Problem 3 3
Failure to Cut 2 2
Defective Device 2 2
Physical Resistance/Sticking 2 2
Material Deformation 1 1
Unintended Movement 1 1
Leak/Splash 1 1
Device Damaged by Another Device 1 1
Sharp Edges 1 1
Therapeutic or Diagnostic Output Failure 1 1
Activation Problem 1 1
Connection Problem 1 1
Activation Failure 1 1
Failure to Advance 1 1
Tear, Rip or Hole in Device Packaging 1 1
Product Quality Problem 1 1
Material Integrity Problem 1 1
Device Fell 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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