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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, surgical, orthopedic, pneumatic powered & accessory/attachment
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHSZ
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2016 27 27
2017 24 24
2018 13 13
2019 5 5
2020 13 13
2021 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23 23
Material Rupture 16 16
Air Leak 14 14
Leak/Splash 9 9
Burst Container or Vessel 5 5
Failure to Cut 4 4
Device Inoperable 4 4
Noise, Audible 3 3
Fracture 3 3
Overheating of Device 3 3
Use of Device Problem 2 2
Device Operates Differently Than Expected 2 2
Vibration 2 2
Entrapment of Device 2 2
Output below Specifications 2 2
Unintended Movement 1 1
Partial Blockage 1 1
Detachment Of Device Component 1 1
Defective Component 1 1
Dull, Blunt 1 1
Device Displays Incorrect Message 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Temperature Problem 1 1
Insufficient Information 1 1
Mechanical Problem 1 1
Disassembly 1 1
Fluid Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 30 30
No Consequences Or Impact To Patient 26 26
No Patient Involvement 16 16
No Clinical Signs, Symptoms or Conditions 8 8
No Code Available 4 4
Foreign Body In Patient 3 3
Burn(s) 1 1
Laceration(s) 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 The Anspach Effort, Inc. II May-04-2017
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