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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clip, implantable, reprocessed
Definition The "implantable clip, reprocessed" is intended to connect internal tissues to aid in healing. It is not absorbable. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNMJ
Regulation Number 878.4300
Device Class 2

MDR Year MDR Reports MDR Events
2019 11 11
2020 1 1
2021 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Form Staple 13 13
Failure to Fire 5 5
Mechanical Jam 4 4
Patient Device Interaction Problem 3 3
Device Fell 1 1
Contamination /Decontamination Problem 1 1
Difficult to Open or Close 1 1
Defective Device 1 1
Use of Device Problem 1 1
Misfire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
No Consequences Or Impact To Patient 4 4
Blood Loss 4 4
Hemorrhage/Bleeding 3 3
No Patient Involvement 1 1
Fluid Discharge 1 1
No Known Impact Or Consequence To Patient 1 1
No Code Available 1 1
Insufficient Information 1 1

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