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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device laparoscope, general & plastic surgery
Regulation Description Endoscope and accessories.
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 CodeGCJ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BEACON SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING HANGTIAN KADI TECHNOLOGY R&D INSTITUTE
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER LABORATORIES, INC
  SUBSTANTIALLY EQUIVALENT 1
BUFFALO FILTER, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAREFUSION 2200 INC.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 5
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 6
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 2
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELMED
  SUBSTANTIALLY EQUIVALENT 1
ENDOCLOT PLUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ SE & CO KG
  SUBSTANTIALLY EQUIVALENT 3
LAGIS ENTERPRISES CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
LIVAC PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOVASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEON BIODESIGN, INC
  SUBSTANTIALLY EQUIVALENT 4
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NDS SURGICAL IMAGING, LLC.
  SUBSTANTIALLY EQUIVALENT 2
NELIS
  SUBSTANTIALLY EQUIVALENT 1
NEOSURGICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
NOVADAQ TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVATECH S.A.
  SUBSTANTIALLY EQUIVALENT 2
NOVATECH SA
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 1
SANTA BARBARA IMAGING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SONY ELECTRONICS INC.,
  SUBSTANTIALLY EQUIVALENT 2
SONY ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 5
STRYKER
  SUBSTANTIALLY EQUIVALENT 4
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 7
SYMMETRY SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TAIWAN SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WICKIMED SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XODUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 2113
Inflation Problem 1255
Detachment of Device or device Component 1040
Detachment Of Device Component 998
Packaging Problem 777
Material Fragmentation 566
Leak / Splash 491
Difficult to Insert 275
Adverse Event Without Identified Device or Use Problem 274
Difficult to Remove 246
Device Packaging Compromised 223
Material Separation 177
No Display / Image 167
Mechanical Problem 157
Failure to Fire 142
Burst Container or Vessel 140
Gas Leak 136
Mechanics Altered 130
Fracture 125
Noise, Audible 122
Activation, Positioning or Separation Problem 116
Torn Material 103
Material Split, Cut or Torn 98
Material Rupture 95
Loss of or Failure to Bond 91
Air Leak 91
Material Deformation 77
Mechanical Jam 76
Device Operates Differently Than Expected 73
Poor Quality Image 69
Human-Device Interface Problem 65
Failure To Adhere Or Bond 61
Optical Problem 58
Material Perforation 55
Deflation Problem 54
Insufficient Information 47
Failure to Form Staple 46
Needle 45
Hole In Material 44
Misfire 42
Positioning Failure 38
Thermal Decomposition of Device 36
Physical Resistance 36
Bent 35
Device Slipped 35
Failure to Cut 34
Balloon 33
Sparking 33
Display or Visual Feedback Problem 31
Device Contamination with Chemical or Other Material 31
Use of Device Problem 29
Product Quality Problem 29
Tip 28
Tear, Rip or Hole in Device Packaging 28
Decrease in Pressure 28
Difficult to Open or Close 27
Smoking 27
Component Falling 27
Material Integrity Problem 26
Retraction Problem 25
Crack 23
Electrical /Electronic Property Problem 23
Physical Resistance / Sticking 22
Entrapment of Device 22
Fluid Leak 22
Component Missing 21
Overheating of Device 21
Trocar 21
Melted 20
Failure to Advance 19
Device Difficult to Setup or Prepare 19
Erratic or Intermittent Display 19
Sharp Edges 17
Material Puncture / Hole 15
Cut In Material 14
Seal 14
Difficult or Delayed Positioning 13
No Device Output 13
Corroded 12
Fire 12
Communication or Transmission Problem 12
Improper Device Output 12
Dull, Blunt 12
Material Twisted / Bent 11
Appropriate Term/Code Not Available 11
Structural Problem 10
Peeled / Delaminated 10
Device Or Device Fragments Location Unknown 10
Unexpected Shutdown 10
Suture 9
False Device Output 9
Defective Component 9
Loose or Intermittent Connection 9
Endoscope 8
Device Operational Issue 8
Image Display Error / Artifact 8
Out-Of-Box Failure 8
Fitting Problem 7
Device Damaged by Another Device 7
Jaw 7
Total Device Problems 12125

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Jul-11-2019
2 Applied Medical Resources Corp II Jun-14-2017
3 Banyan Medical, LLC II Oct-13-2016
4 Carefusion 2200 Inc I Jul-22-2016
5 Conmed Corporation II May-09-2019
6 Cook Inc. II Jun-08-2017
7 Covidien LLC II Jun-23-2017
8 DeRoyal Industries Inc II May-21-2015
9 EXP Pharmaceutical Services Corp II Jul-24-2015
10 Espiner Medical Ltd II Nov-10-2018
11 Ethicon Endo-Surgery Inc II May-15-2018
12 Genicon, Inc. II May-14-2020
13 Genicon, Inc. II Mar-16-2018
14 Lumenis II Sep-16-2015
15 Novadaq Technologies Inc. II Mar-02-2016
16 Olympus Corporation of the Americas II Apr-22-2020
17 Pentax Medical Company II Jul-23-2016
18 Pentax Medical Company II Jun-28-2016
19 Stryker Corporation II Mar-02-2018
20 Teleflex Medical II Oct-07-2016
21 US Endoscopy Group Inc III Mar-08-2017

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