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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clamp, surgical, general & plastic surgery
Product CodeGDJ
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 14 14
2020 7 7
2021 25 25
2022 20 20
2023 29 29
2024 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Misassembled 44 44
Break 28 28
Failure to Fire 21 21
Detachment of Device or Device Component 17 17
Failure to Form Staple 12 12
Fracture 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Difficult to Open or Close 8 8
Entrapment of Device 5 5
Difficult to Remove 4 4
Device Slipped 2 2
Unraveled Material 2 2
Misfire 2 2
Mechanical Problem 1 1
Device Fell 1 1
Device Difficult to Setup or Prepare 1 1
Use of Device Problem 1 1
Component Missing 1 1
Mechanics Altered 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Loss of or Failure to Bond 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 12 12
Insufficient Information 11 11
Unspecified Tissue Injury 6 6
No Known Impact Or Consequence To Patient 5 5
Failure to Anastomose 3 3
Hemorrhage/Bleeding 3 3
No Patient Involvement 2 2
Tissue Breakdown 2 2
No Information 1 1
Peritonitis 1 1
Post Operative Wound Infection 1 1
Foreign Body In Patient 1 1
Laceration(s) 1 1
Abscess 1 1
Ascites 1 1
Fistula 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Perfusion Systems II Jul-23-2024
2 Medtronic Perfusion Systems II May-10-2024
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