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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 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Misassembled 44 44
Break 27 27
Failure to Fire 20 20
Detachment of Device or Device Component 16 16
Failure to Form Staple 12 12
Fracture 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Difficult to Open or Close 7 7
Entrapment of Device 5 5
Difficult to Remove 4 4
Device Slipped 2 2
Unraveled Material 2 2
Misfire 2 2
Loss of or Failure to Bond 1 1
Device Difficult to Setup or Prepare 1 1
Device Dislodged or Dislocated 1 1
Mechanics Altered 1 1
Use of Device Problem 1 1
Component Missing 1 1
Mechanical Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 108 108
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
Foreign Body In Patient 1 1
No Information 1 1
Laceration(s) 1 1
Abscess 1 1
Fistula 1 1
Peritonitis 1 1
Post Operative Wound Infection 1 1
Ascites 1 1

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