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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, surgical with orthopedic accessories, ac-powered
Product CodeJEA
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2018 60 60
2019 63 63
2020 46 46
2021 40 40
2022 32 32
2023 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 61 61
Insufficient Information 31 31
Adverse Event Without Identified Device or Use Problem 27 27
Unintended System Motion 22 22
Use of Device Problem 21 21
Device Slipped 19 19
Improper or Incorrect Procedure or Method 17 17
Mechanical Problem 13 13
Fracture 9 9
Detachment of Device or Device Component 9 9
Device Fell 9 9
Device Operates Differently Than Expected 7 7
Device Dislodged or Dislocated 7 7
Unexpected Shutdown 6 6
Positioning Problem 6 6
Break 6 6
Crack 5 5
Electrical Shorting 5 5
Patient-Device Incompatibility 4 4
Device Handling Problem 4 4
Misassembly by Users 4 4
Loss of or Failure to Bond 4 4
Detachment Of Device Component 3 3
Positioning Failure 3 3
Defective Component 3 3
Device Issue 3 3
No Apparent Adverse Event 3 3
Activation, Positioning or Separation Problem 3 3
Device Operational Issue 3 3
Output Problem 3 3
Mechanical Jam 3 3
Physical Property Issue 2 2
Connection Problem 2 2
Unintended Collision 2 2
Malposition of Device 2 2
Patient Device Interaction Problem 2 2
Smoking 2 2
Overheating of Device 2 2
Inadequate Instructions for Healthcare Professional 2 2
Loose or Intermittent Connection 2 2
Electrical /Electronic Property Problem 2 2
Component Falling 2 2
Circuit Failure 2 2
Corroded 2 2
Intermittent Continuity 2 2
Use of Incorrect Control/Treatment Settings 1 1
Collapse 1 1
Computer Software Problem 1 1
Entrapment of Device 1 1
Fire 1 1
Disassembly 1 1
Disconnection 1 1
Degraded 1 1
Material Too Rigid or Stiff 1 1
Self-Activation or Keying 1 1
Material Separation 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Moisture Damage 1 1
Structural Problem 1 1
Defective Device 1 1
Component Missing 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Unintended Electrical Shock 1 1
Incomplete or Inadequate Connection 1 1
Failure to Clean Adequately 1 1
Key or Button Unresponsive/not Working 1 1
Noise, Audible 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Ambient Temperature Problem 1 1
Application Program Problem 1 1
Battery Problem 1 1
Communication or Transmission Problem 1 1
Human Factors Issue 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 81 81
No Clinical Signs, Symptoms or Conditions 57 57
Fall 48 48
Insufficient Information 18 18
No Consequences Or Impact To Patient 15 15
Pressure Sores 12 12
Injury 9 9
Bone Fracture(s) 8 8
Erythema 7 7
Laceration(s) 6 6
No Information 6 6
Pain 5 5
Abrasion 3 3
Bruise/Contusion 3 3
Hematoma 3 3
Unintended Extubation 3 3
Nervous System Injury 3 3
Numbness 3 3
No Patient Involvement 3 3
Skin Tears 3 3
Stenosis 2 2
Spinal Cord Injury 2 2
Vertebral Fracture 2 2
Muscle/Tendon Damage 2 2
Burn(s) 2 2
Paralysis 2 2
Neurological Deficit/Dysfunction 2 2
Damage to Ligament(s) 2 2
Skin Irritation 2 2
Swelling 2 2
Burning Sensation 1 1
Concussion 1 1
Skull Fracture 1 1
Spinal Column Injury 1 1
Fracture, Arm 1 1
Extubate 1 1
Memory Loss/Impairment 1 1
Muscle Weakness 1 1
Necrosis 1 1
Neuropathy 1 1
Perforation 1 1
Cardiac Arrest 1 1
Contusion 1 1
Arrhythmia 1 1
Abdominal Pain 1 1
Hemorrhage, Subarachnoid 1 1
Low Blood Pressure/ Hypotension 1 1
Incontinence 1 1
Irritation 1 1
Head Injury 1 1
Headache 1 1
Blister 1 1
Swelling/ Edema 1 1
No Code Available 1 1
Respiratory Insufficiency 1 1
Limb Fracture 1 1
Neck Pain 1 1
Skin Inflammation 1 1
Paraplegia 1 1
Low Oxygen Saturation 1 1
Irritability 1 1
Ambulation Difficulties 1 1
Cognitive Changes 1 1
Electric Shock 1 1
Lethargy 1 1
Blood Loss 1 1
Tissue Breakdown 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mizuho OSI II Oct-09-2020
2 Steris Corporation II Feb-24-2021
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