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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
2019 59 59
2020 40 40
2021 26 26
2022 38 38
2023 54 54
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Open or Close 59 59
Failure to Align 30 30
Break 24 24
Difficult to Remove 14 14
Failure to Cut 13 13
Difficult to Open or Remove Packaging Material 13 13
Detachment of Device or Device Component 13 13
Packaging Problem 12 12
Material Twisted/Bent 10 10
Appropriate Term/Code Not Available 10 10
Device Reprocessing Problem 9 9
Mechanical Problem 8 8
Tear, Rip or Hole in Device Packaging 7 7
Dull, Blunt 7 7
Adverse Event Without Identified Device or Use Problem 6 6
Device Handling Problem 5 5
Component Misassembled 5 5
Entrapment of Device 5 5
Fracture 5 5
Contamination 5 5
Nonstandard Device 4 4
Failure to Clean Adequately 4 4
Material Split, Cut or Torn 3 3
Deformation Due to Compressive Stress 3 3
Device Damaged by Another Device 2 2
Difficult to Advance 2 2
Physical Resistance/Sticking 2 2
Use of Device Problem 2 2
Corroded 2 2
Material Protrusion/Extrusion 2 2
Material Fragmentation 1 1
Migration or Expulsion of Device 1 1
Improper or Incorrect Procedure or Method 1 1
Component Missing 1 1
Solder Joint Fracture 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Non Reproducible Results 1 1
No Apparent Adverse Event 1 1
Device Dislodged or Dislocated 1 1
Separation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 111 111
No Consequences Or Impact To Patient 63 63
No Patient Involvement 17 17
Hemostasis 8 8
Foreign Body In Patient 7 7
Tissue Damage 6 6
No Known Impact Or Consequence To Patient 5 5
Hemorrhage/Bleeding 4 4
No Code Available 3 3
Gastrointestinal Hemorrhage 2 2
Device Embedded In Tissue or Plaque 2 2
Hematoma 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Injury 1 1
Laceration(s) of Esophagus 1 1
Edema 1 1
Inflammation 1 1
Laceration(s) 1 1
Perforation 1 1
Pancreatitis 1 1
Unspecified Hepatic or Biliary Problem 1 1

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