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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
Regulation Description Endoscope and accessories.
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
2021 26 26
2022 38 38
2023 54 54
2024 42 42
2025 33 33
2026 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 63 63
Break 23 23
Detachment of Device or Device Component 16 16
Device Reprocessing Problem 14 14
Difficult to Open or Remove Packaging Material 13 13
Material Twisted/Bent 12 12
Packaging Problem 12 12
Fracture 11 11
Nonstandard Device 11 11
Mechanical Problem 10 10
Tear, Rip or Hole in Device Packaging 10 10
Failure to Cut 10 10
Difficult to Remove 9 9
Entrapment of Device 7 7
Failure to Clean Adequately 7 7
Contamination 6 6
Mechanical Jam 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Component Misassembled 5 5
Material Split, Cut or Torn 4 4
Appropriate Term/Code Not Available 3 3
Deformation Due to Compressive Stress 3 3
Difficult to Advance 2 2
Insufficient Information 2 2
Corroded 2 2
Use of Device Problem 2 2
Component Missing 1 1
Delivered as Unsterile Product 1 1
Off-Label Use 1 1
Retraction Problem 1 1
Material Separation 1 1
Problem with Sterilization 1 1
Thermal Decomposition of Device 1 1
Material Fragmentation 1 1
No Apparent Adverse Event 1 1
Device Damaged by Another Device 1 1
Contamination /Decontamination Problem 1 1
Device Dislodged or Dislocated 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Device Handling Problem 1 1
Physical Resistance/Sticking 1 1
Non Reproducible Results 1 1
Difficult or Delayed Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 184 184
Foreign Body In Patient 5 5
Hemorrhage/Bleeding 5 5
Gastrointestinal Hemorrhage 4 4
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pancreatitis 1 1
No Code Available 1 1
Inflammation 1 1
Perforation 1 1
Laceration(s) 1 1
Unspecified Hepatic or Biliary Problem 1 1
Ulcer 1 1
Fibrosis 1 1

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