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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device arthroscope
Regulation Description Arthroscope.
Definition Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeHRX
Regulation Number 888.1100
Device Class 2


Premarket Reviews
ManufacturerDecision
A.M. SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOPSYBELL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BIOVISION TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
CONMED
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
HYDROCISION
  SUBSTANTIALLY EQUIVALENT 2
HYDROCISION, INC.
  SUBSTANTIALLY EQUIVALENT 2
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRATED ENDOSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROAIRE SURGICAL INSTRUMENTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PROSURG, INC
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
RENOVO, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
TRICE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE AG
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Electrical Shorting 385
Break 360
Material Rupture 310
Overfill 219
Overheating of Device 181
Suction Failure 179
Poor Quality Image 178
Increase in Pressure 167
Detachment of Device or device Component 164
Leak / Splash 115
Fluid Leak 98
Material Disintegration 87
Adverse Event Without Identified Device or Use Problem 87
Metal Shedding Debris 78
Intermittent Continuity 76
Suction Problem 74
Material Fragmentation 73
Pressure Problem 72
Insufficient Information 72
Excess Flow or Over-Infusion 70
Disassembly 67
Positioning Problem 62
Intermittent loss of power 61
Mechanical Jam 52
Device-Device Incompatibility 50
Peeled / Delaminated 48
Device Remains Activated 47
Device Operates Differently Than Expected 44
Failure to Power Up 44
Intermittent Energy Output 40
Filling Problem 34
Mechanical Problem 33
Electrical /Electronic Property Problem 32
No Display / Image 30
Device Stops Intermittently 28
Device Contamination with Chemical or Other Material 27
Unintended System Motion 25
Loss of or Failure to Bond 24
Inflation Problem 19
Fail-Safe Problem 19
Appropriate Term/Code Not Available 19
Defective Component 18
Unintended Movement 18
Unintended power up 17
Optical Problem 16
Fracture 15
Use of Device Problem 14
Smoking 14
Detachment Of Device Component 13
Deflation Problem 13
Loose or Intermittent Connection 13
Incomplete or Inadequate Connection 13
Self-Activation or Keying 12
Unknown (for use when the device problem is not known) 10
Migration or Expulsion of Device 9
Delivered as Unsterile Product 9
Corroded 9
Circuit Failure 9
Device Inoperable 8
Particulates 8
Device Operational Issue 8
Device Displays Incorrect Message 8
Physical Resistance / Sticking 8
Electrical Power Problem 8
Component Incompatible 8
Material Deformation 7
Material Integrity Problem 7
Material Puncture / Hole 7
Failure to Disconnect 7
Noise, Audible 7
Scratched Material 6
Short Fill 6
Backflow 6
Packaging Problem 6
Unexpected Shutdown 6
Material Separation 6
Material Twisted / Bent 6
Image Display Error / Artifact 6
Failure to Advance 6
Bent 5
Sticking 5
Crack 5
Improper Flow or Infusion 5
Fogging 5
Burst Container or Vessel 4
Incomplete Coaptation 4
Device Slipped 4
Component Missing 4
Misfocusing 4
Coagulation in Device or device Ingredient 4
Unintended Ejection 4
Image Orientation Incorrect 4
Partial Blockage 4
Tear, Rip or Hole in Device Packaging 4
Device Damaged by Another Device 3
Misconnection 3
Optical Distortion 3
Operating System Becomes Nonfunctional 3
Accessory Incompatible 3
Activation Problem 3
Total Device Problems 4300

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 Customed, Inc II Sep-03-2015
3 DePuy Mitek, Inc., a Johnson & Johnson Co. II Jan-15-2016
4 Instratek, Incorporated II Dec-22-2015
5 Medical Vision Ab II Aug-30-2016
6 Medtronic Sofamor Danek USA Inc II Jun-16-2020
7 MicroAire Surgical Instruments, LLC II Aug-08-2019
8 MicroAire Surgical Instruments, LLC II May-25-2018
9 Myelotec, Inc. II Jul-28-2017
10 Richard Wolf GmbH II Aug-22-2018
11 Richard Wolf Medical Instruments Corp. II Feb-09-2016
12 Stryker GmbH II Aug-28-2019
13 Stryker GmbH II Jun-20-2019
14 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
15 Stryker Sustainability Solutions II Mar-05-2019

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