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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 3
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 6
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 7
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 2
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU TK MEDICAL INSTRUMENT CO., LTD.
  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 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
SONY ELECTRONICS INC.,
  SUBSTANTIALLY EQUIVALENT 2
SONY ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 5
STRYKER
  SUBSTANTIALLY EQUIVALENT 5
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 8
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

MDR Year MDR Reports MDR Events
2015 1709 1709
2016 2077 2077
2017 3462 3462
2018 2562 2562
2019 2578 2578
2020 1521 1521

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3229 3229
Inflation Problem 1476 1476
Detachment of Device or Device Component 1286 1286
Detachment Of Device Component 1239 1239
Packaging Problem 835 835
Material Fragmentation 664 664
Leak/Splash 580 580
No Display/Image 529 529
Adverse Event Without Identified Device or Use Problem 403 403
Difficult to Insert 316 316
Device Operates Differently Than Expected 280 280
Difficult to Remove 272 272
Device Packaging Compromised 266 266
Balloon 232 232
Material Separation 229 229
Tip 226 226
Poor Quality Image 226 226
Torn Material 210 210
Material Rupture 197 197
Mechanical Problem 195 195
Burst Container or Vessel 186 186
Gas Leak 170 170
Trocar 163 163
Failure to Fire 162 162
Material Split, Cut or Torn 161 161
Component Falling 142 142
Mechanics Altered 140 140
Noise, Audible 140 140
Fracture 140 140
Activation, Positioning or SeparationProblem 125 125
Air Leak 124 124
Insufficient Information 119 119
Loss of or Failure to Bond 106 106
Crack 102 102
Material Deformation 102 102
Device Contamination with Chemical or Other Material 98 98
Overheating of Device 93 93
Mechanical Jam 92 92
Component Missing 90 90
Bag 89 89
Bent 77 77
Hole In Material 71 71
Optical Problem 71 71
Tear, Rip or Hole in Device Packaging 68 68
Human-Device Interface Problem 68 68
Electrical Shorting 66 66
Failure To Adhere Or Bond 64 64
Display or Visual Feedback Problem 64 64
Needle 62 62
Failure to Form Staple 61 61
Device Slipped 60 60
Melted 60 60
Cannula 60 60
Deflation Problem 59 59
Seal 58 58
Material Perforation 58 58
Material Integrity Problem 57 57
Fluid Leak 53 53
Retraction Problem 52 52
Difficult to Open or Close 52 52
Electrical /Electronic Property Problem 52 52
Misfire 52 52
Thermal Decomposition of Device 51 51
Sparking 51 51
Positioning Failure 51 51
Loose or Intermittent Connection 50 50
Defective Device 49 49
Valve(s) 46 46
Smoking 45 45
Communication or Transmission Problem 43 43
Decrease in Pressure 42 42
Failure to Cut 41 41
Use of Device Problem 40 40
Device Fell 40 40
Contamination /Decontamination Problem 39 39
Physical Resistance 39 39
Device Or Device Fragments Location Unknown 38 38
Image Display Error/Artifact 38 38
Entrapment of Device 37 37
Physical Resistance/Sticking 37 37
Failure to Advance 36 36
Jaw 35 35
Appropriate Term/Code Not Available 35 35
Knife 34 34
Screen 34 34
Product Quality Problem 32 32
Insulation 32 32
Cap 32 32
Material Twisted/Bent 31 31
Fitting Problem 30 30
Defective Component 30 30
Erratic or Intermittent Display 30 30
Shaft 28 28
Device Dislodged or Dislocated 28 28
Loss of Power 27 27
Temperature Problem 27 27
Delivered as Unsterile Product 27 27
Material Puncture/Hole 26 26
Sticking 24 24
Device Inoperable 24 24

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6066 6066
No Consequences Or Impact To Patient 5500 5500
No Patient Involvement 583 583
No Information 527 527
No Code Available 417 417
Foreign Body In Patient 261 261
Device Embedded In Tissue or Plaque 186 186
Tissue Damage 162 162
Injury 134 134
Hemorrhage/Bleeding 89 89
Blood Loss 87 87
Cancer 83 83
Death 71 71
Burn(s) 43 43
Radiation Exposure, Unintended 41 41
Burn, Thermal 39 39
Unspecified Infection 35 35
Pain 35 35
Failure to Anastomose 30 30
Hernia 28 28
Patient Problem/Medical Problem 21 21
Hematoma 21 21
Laceration(s) 21 21
Post Operative Wound Infection 20 20
Obstruction/Occlusion 18 18
Not Applicable 18 18
Abdominal Pain 18 18
Abscess 15 15
Perforation 15 15
Seroma 13 13
Bowel Perforation 12 12
Perforation of Vessels 12 12
Other (for use when an appropriate patient code cannot be identified) 11 11
Foreign body, removal of 11 11
Complaint, Ill-Defined 10 10
Peritonitis 10 10
Urinary Retention 9 9
Adhesion(s) 8 8
Fever 7 7
Discomfort 7 7
Surgery, prolonged 6 6
Electric Shock 6 6
Skin Irritation 6 6
Internal Organ Perforation 6 6
Inflammation 6 6
Pulmonary Emphysema 5 5
Cardiac Arrest 5 5
Partial thickness (Second Degree) Burn 5 5
Full thickness (Third Degree) Burn 5 5
Sepsis 5 5
Great Vessel Perforation 5 5
Vomiting 4 4
Exsanguination 4 4
Pneumothorax 4 4
Swelling 4 4
Liver Laceration(s) 3 3
Nausea 3 3
Necrosis 3 3
Fistula 3 3
Erythema 3 3
Pulmonary Embolism 3 3
Exposure to Body Fluids 3 3
Wound Dehiscence 3 3
Blurred Vision 3 3
Urinary Tract Infection 3 3
Rupture 3 3
Surgical procedure 3 3
Impaired Healing 3 3
Vascular Dissection 3 3
Missing Value Reason 3 3
Superficial (First Degree) Burn 3 3
Skin Tears 3 3
Reaction 2 2
Numbness 2 2
Surgical procedure, additional 2 2
Fibrosis 2 2
Constipation 2 2
Inadequate Pain Relief 2 2
Cardiac Tamponade 2 2
Ulcer 2 2
Erosion 2 2
Bruise/Contusion 2 2
Cyst(s) 2 2
Extravasation 2 2
Nerve Damage 2 2
Occlusion 2 2
Hemostasis 2 2
Shock 2 2
Respiratory Distress 2 2
Phlebitis 2 2
Myocardial Infarction 2 2
Peritoneal Laceration(s) 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Surgical procedure, repeated 1 1
Scarring 1 1
Swollen Lymph Nodes 1 1
Thrombosis 1 1
Thrombus 1 1
Hypovolemic Shock 1 1

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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