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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, exempt
Definition This product code is the class II exempt counterpart of OCZ, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 876.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodePTS
Regulation Number 876.1500
Device Class 2

MDR Year MDR Reports MDR Events
2020 40 40
2021 26 26
2022 38 38
2023 54 54
2024 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 57 57
Break 25 25
Detachment of Device or Device Component 15 15
Difficult to Open or Remove Packaging Material 13 13
Failure to Cut 13 13
Failure to Align 12 12
Packaging Problem 12 12
Difficult to Remove 11 11
Fracture 11 11
Nonstandard Device 11 11
Material Twisted/Bent 10 10
Device Reprocessing Problem 10 10
Mechanical Problem 8 8
Tear, Rip or Hole in Device Packaging 8 8
Entrapment of Device 7 7
Failure to Clean Adequately 7 7
Component Misassembled 7 7
Contamination 6 6
Appropriate Term/Code Not Available 6 6
Material Split, Cut or Torn 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Deformation Due to Compressive Stress 3 3
Physical Resistance/Sticking 2 2
Difficult to Advance 2 2
Use of Device Problem 2 2
Device Damaged by Another Device 2 2
Material Protrusion/Extrusion 2 2
Corroded 2 2
Off-Label Use 1 1
Non Reproducible Results 1 1
Separation Failure 1 1
Insufficient Information 1 1
Material Fragmentation 1 1
Component Missing 1 1
Thermal Decomposition of Device 1 1
Problem with Sterilization 1 1
Device Handling Problem 1 1
No Apparent Adverse Event 1 1
Device Dislodged or Dislocated 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 147 147
No Consequences Or Impact To Patient 22 22
No Patient Involvement 12 12
Foreign Body In Patient 5 5
No Code Available 3 3
Insufficient Information 3 3
Gastrointestinal Hemorrhage 2 2
No Known Impact Or Consequence To Patient 2 2
Hemostasis 2 2
Hemorrhage/Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pancreatitis 1 1
Inflammation 1 1
Perforation 1 1
Laceration(s) of Esophagus 1 1
Unspecified Hepatic or Biliary Problem 1 1
Device Embedded In Tissue or Plaque 1 1

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