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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 2
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 2
CONMED
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GALLINI MEDICAL DEVICES, SRL
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
HYDROCISION
  SUBSTANTIALLY EQUIVALENT 1
HYDROCISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMEDICOM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INTEGRATED ENDOSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
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
ORTHOPEDIC SCIENCES,
  SUBSTANTIALLY EQUIVALENT 1
PROSURG, INC
  SUBSTANTIALLY EQUIVALENT 1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
RENOVO, INC
  SUBSTANTIALLY EQUIVALENT 1
RZ MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SCHOLLY FIBEROPTIC
  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
TRICE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VISIONSENSE LTD.
  SUBSTANTIALLY EQUIVALENT 1
W.O.M. WORLD OF MEDICINE AG
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Electrical Shorting 304
Material Rupture 284
Break 239
Overfill 202
Suction Failure 159
Overheating of Device 141
Increase in Pressure 139
Detachment of Device or device Component 121
Poor Quality Image 103
Leak / Splash 103
Metal Shedding Debris 96
Fluid Leak 87
Adverse Event Without Identified Device or Use Problem 79
Material Disintegration 76
Suction Problem 74
Material Fragmentation 72
Disassembly 67
Pressure Problem 65
Intermittent Continuity 65
Excess Flow or Over-Infusion 61
Intermittent loss of power 59
Positioning Problem 57
Insufficient Information 54
Mechanical Jam 48
Device Operates Differently Than Expected 44
Peeled / Delaminated 43
Failure to Power Up 42
Device Remains Activated 41
Intermittent Energy Output 39
Filling Problem 34
Mechanical Problem 31
Device Stops Intermittently 28
No Display / Image 28
Loss of or Failure to Bond 22
Device Contamination with Chemical or Other Material 20
Unintended System Motion 20
Appropriate Term/Code Not Available 18
Device-Device Incompatibility 18
Fail-Safe Problem 17
Unintended Movement 17
Unintended power up 16
Defective Component 16
Use of Device Problem 13
Inflation Problem 13
Detachment Of Device Component 13
Fracture 12
Loose or Intermittent Connection 11
Incomplete or Inadequate Connection 11
Electrical /Electronic Property Problem 11
Unknown (for use when the device problem is not known) 11
Deflation Problem 10
Smoking 10
Self-Activation or Keying 9
Migration or Expulsion of Device 9
Noise, Audible 9
Physical Resistance / Sticking 8
Device Displays Incorrect Message 8
Device Operational Issue 8
Device Inoperable 8
Corroded 7
Delivered as Unsterile Product 7
Failure to Disconnect 6
Unexpected Shutdown 6
Electrical Power Problem 6
Component Incompatible 6
Failure to Advance 6
Material Deformation 6
Material Twisted / Bent 5
Bent 5
Material Integrity Problem 5
Packaging Problem 5
Sticking 5
Improper Flow or Infusion 5
Component Missing 5
Scratched Material 5
Short Fill 5
Burst Container or Vessel 4
Incomplete Coaptation 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
Image Display Error / Artifact 4
Optical Problem 3
Accessory Incompatible 3
Operating System Becomes Nonfunctional 3
Vibration 3
Device Damaged by Another Device 3
Material Separation 3
Crack 3
Material Puncture / Hole 3
Unstable 3
Activation Problem 3
Circuit Failure 3
Decrease in Suction 3
Increased Pump Speed 3
Insufficient Flow or Under Infusion 3
Connection Problem 2
Total Device Problems 3598

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 MicroAire Surgical Instruments, LLC II Aug-08-2019
7 MicroAire Surgical Instruments, LLC II May-25-2018
8 Myelotec, Inc. II Jul-28-2017
9 Richard Wolf GmbH II Aug-22-2018
10 Richard Wolf Medical Instruments Corp. II Feb-09-2016
11 Stryker Endoscopy II Jun-25-2014
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
16 The Anspach Effort, Inc. II Jun-25-2014

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