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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 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Break 44 44
Difficult to Open or Close 20 20
Adverse Event Without Identified Device or Use Problem 14 14
Material Separation 8 8
Material Fragmentation 7 7
Detachment of Device or Device Component 6 6
Difficult to Remove 5 5
Arcing 4 4
Insufficient Information 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
Material Twisted/Bent 3 3
Temperature Problem 3 3
Mechanics Altered 3 3
Unintended Movement 2 2
Physical Resistance/Sticking 2 2
Mechanical Jam 2 2
Failure to Cut 2 2
Defective Device 2 2
Connection Problem 1 1
Unsealed Device Packaging 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
Packaging Problem 1 1
Device Damaged by Another Device 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Sharp Edges 1 1
Device Fell 1 1
Activation Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 54 54
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
Hemorrhage/Bleeding 4 4
Burn(s) 3 3
Superficial (First Degree) Burn 3 3
Abdominal Distention 2 2
Perforation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Device Embedded In Tissue or Plaque 2 2
Partial thickness (Second Degree) Burn 1 1
Pericardial Effusion 1 1
Unspecified Kidney or Urinary Problem 1 1
Blister 1 1
Tissue Damage 1 1
Death 1 1
Granuloma 1 1
Low Blood Pressure/ Hypotension 1 1
Laceration(s) 1 1
Pain 1 1
No Patient Involvement 1 1
Bowel Perforation 1 1
Abdominal Pain 1 1
Patient Problem/Medical Problem 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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