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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
ENVISION ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 21 21
2021 20 20
2022 33 33
2023 25 25
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Break 40 40
Difficult to Open or Close 21 21
Adverse Event Without Identified Device or Use Problem 14 14
Material Fragmentation 9 9
Material Separation 9 9
Detachment of Device or Device Component 7 7
Insufficient Information 5 5
Difficult to Remove 4 4
Arcing 4 4
Mechanical Problem 3 3
Material Twisted/Bent 3 3
Mechanics Altered 3 3
Flushing Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Temperature Problem 3 3
Activation, Positioning or Separation Problem 2 2
Entrapment of Device 2 2
Physical Resistance/Sticking 2 2
Unintended Movement 2 2
Defective Device 2 2
Failure to Cut 2 2
Mechanical Jam 2 2
Unexpected Shutdown 1 1
Activation Problem 1 1
Device Fell 1 1
Unsealed Device Packaging 1 1
Material Integrity Problem 1 1
Use of Device Problem 1 1
Device Damaged by Another Device 1 1
Sharp Edges 1 1
Material Deformation 1 1
Packaging Problem 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Activation Failure 1 1
Device Reprocessing Problem 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 68 68
Insufficient Information 24 24
Foreign Body In Patient 15 15
No Code Available 5 5
No Consequences Or Impact To Patient 5 5
Superficial (First Degree) Burn 4 4
No Known Impact Or Consequence To Patient 4 4
Laceration(s) 4 4
Burn(s) 3 3
Hemorrhage/Bleeding 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Perforation 2 2
Patient Problem/Medical Problem 1 1
Abdominal Pain 1 1
Death 1 1
Bowel Perforation 1 1
Abdominal Distention 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
Device Embedded In Tissue or Plaque 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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