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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 1
BEIJING HANGTIAN KADI TECHNOLOGY R&D INSTITUTE
  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 5
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
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 2
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 2
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 3
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NDS SURGICAL IMAGING, LLC.
  SUBSTANTIALLY EQUIVALENT 2
NEOSURGICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
NOVADAQ TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVATECH S.A.
  SUBSTANTIALLY EQUIVALENT 2
NOVATECH SA
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
PROSURG, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 3
SONY ELECTRONICS INC.,
  SUBSTANTIALLY EQUIVALENT 2
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 5
STRYKER
  SUBSTANTIALLY EQUIVALENT 7
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 9
SYMMETRY SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
WICKIMED SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XODUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2079 2284
2017 3467 3467
2018 2562 2562
2019 2578 2578
2020 2619 2619
2021 730 730

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2922 2974
Inflation Problem 1431 1513
Detachment of Device or Device Component 1388 1388
Detachment Of Device Component 1123 1133
No Display/Image 992 992
Packaging Problem 932 933
Material Fragmentation 665 665
Leak/Splash 600 600
Adverse Event Without Identified Device or Use Problem 404 405
Difficult to Insert 310 351
Poor Quality Image 288 288
Difficult to Remove 269 270
Device Packaging Compromised 252 263
Mechanical Problem 228 228
Material Split, Cut or Torn 213 213
Material Separation 197 197
Material Rupture 194 194
Failure to Fire 176 176
Device Operates Differently Than Expected 171 171
Gas Leak 167 167
Torn Material 165 167
Mechanics Altered 148 148
Noise, Audible 141 142
Communication or Transmission Problem 136 136
Fracture 135 135
Loss of or Failure to Bond 135 135
Burst Container or Vessel 132 132
Activation, Positioning or SeparationProblem 121 121
Overheating of Device 99 99
Insufficient Information 97 97
Mechanical Jam 97 97
Material Deformation 96 96
Device Contamination with Chemical or Other Material 91 91
Crack 88 88
Optical Problem 86 86
Tear, Rip or Hole in Device Packaging 85 85
Display or Visual Feedback Problem 81 81
Air Leak 71 71
Component Missing 71 71
Electrical Shorting 68 68
Human-Device Interface Problem 65 65
Component Falling 65 65
Erratic or Intermittent Display 63 63
Decrease in Pressure 63 63
Material Integrity Problem 63 63
Failure to Form Staple 62 62
Fluid Leak 62 62
Failure To Adhere Or Bond 62 62
Contamination /Decontamination Problem 61 61
Bent 59 59
Material Perforation 57 57
Device Slipped 56 56
Hole In Material 56 56
Electrical /Electronic Property Problem 55 55
Deflation Problem 54 54
Misfire 54 54
Positioning Failure 51 51
Melted 51 51
Difficult to Open or Close 48 48
Defective Device 47 47
Sparking 46 46
Product Quality Problem 45 45
Retraction Problem 42 42
Image Display Error/Artifact 41 41
Material Twisted/Bent 41 41
Device Fell 40 40
Use of Device Problem 40 40
Delivered as Unsterile Product 37 37
Physical Resistance/Sticking 37 37
Physical Resistance 36 36
Entrapment of Device 36 36
Appropriate Term/Code Not Available 34 34
Failure to Cut 33 34
Smoking 32 32
Material Puncture/Hole 31 31
Thermal Decomposition of Device 31 31
Failure to Power Up 29 29
Defective Component 28 28
Failure to Advance 28 28
Loss of Power 27 27
Temperature Problem 25 25
Output Problem 24 24
Device Dislodged or Dislocated 24 24
Application Program Problem 22 22
Device Difficult to Setup or Prepare 22 22
Sharp Edges 20 20
Device Inoperable 19 19
Corroded 18 18
Device Displays Incorrect Message 18 18
Cut In Material 18 18
Device Or Device Fragments Location Unknown 17 17
Connection Problem 17 17
Fire 17 17
No Device Output 17 17
Fogging 16 16
Improper Device Output 16 16
Unexpected Shutdown 15 15
Material Protrusion/Extrusion 15 16
Peeled/Delaminated 15 15
Device Damaged Prior to Use 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 5792 5792
No Known Impact Or Consequence To Patient 5279 5443
No Clinical Signs, Symptoms or Conditions 849 849
No Patient Involvement 657 658
No Information 502 542
No Code Available 395 395
Foreign Body In Patient 250 250
Device Embedded In Tissue or Plaque 154 154
Insufficient Information 136 136
Injury 128 128
Tissue Damage 112 112
Blood Loss 83 83
Death 57 57
Cancer 52 52
Radiation Exposure, Unintended 40 40
Burn, Thermal 39 39
Unspecified Infection 38 38
Failure to Anastomose 38 38
Burn(s) 36 36
Pain 36 36
Patient Problem/Medical Problem 26 26
Hernia 25 25
Hematoma 23 23
Unspecified Tissue Injury 23 23
Hemorrhage/Bleeding 23 23
Obstruction/Occlusion 20 20
Post Operative Wound Infection 20 20
Abdominal Pain 17 17
Not Applicable 16 16
Abscess 16 16
Laceration(s) 15 15
Seroma 14 14
Perforation 12 12
Peritonitis 11 11
Bowel Perforation 11 11
Urinary Retention 9 9
Adhesion(s) 8 8
Electric Shock 7 7
Perforation of Vessels 7 7
Sepsis 6 6
Fever 6 6
Inflammation 5 5
Skin Irritation 5 5
Partial thickness (Second Degree) Burn 5 5
Discomfort 5 5
Full thickness (Third Degree) Burn 4 4
Cardiac Arrest 4 4
Internal Organ Perforation 4 4
Exsanguination 4 4
Pulmonary Emphysema 3 3
Erythema 3 3
Pulmonary Embolism 3 3
Swelling 3 3
Vascular Dissection 3 3
Unintended Radiation Exposure 3 3
Superficial (First Degree) Burn 3 3
Nausea 3 3
Necrosis 3 3
Fistula 3 3
Missing Value Reason 3 3
Constipation 3 3
Complaint, Ill-Defined 3 3
Vomiting 3 3
Impaired Healing 3 3
Inadequate Pain Relief 2 2
Burning Sensation 2 2
Great Vessel Perforation 2 2
Liver Laceration(s) 2 2
Myocardial Infarction 2 2
Nerve Damage 2 2
Hemostasis 2 2
Incontinence 2 2
Phlebitis 2 2
Bruise/Contusion 2 2
Urinary Tract Infection 2 2
Blurred Vision 2 2
Shock from Patient Lead(s) 2 2
Skin Tears 2 2
Rupture 2 2
Cardiac Tamponade 2 2
Excessive Tear Production 2 2
Ulcer 2 2
Numbness 2 2
Prolapse 2 2
Occlusion 2 2
Abrasion 2 2
Wound Dehiscence 2 2
Erosion 2 2
Bowel Burn 2 2
Extravasation 2 2
Cyst(s) 2 2
Dysphagia/ Odynophagia 1 1
Dyspnea 1 1
Fatigue 1 1
Anemia 1 1
Arthritis 1 1
Vessel Or Plaque, Device Embedded In 1 1
Hypovolemic Shock 1 1
Irritation 1 1
Ischemia 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 Espiner Medical Ltd II Nov-10-2018
9 Ethicon Endo-Surgery Inc II May-15-2018
10 Genicon, Inc. II May-14-2020
11 Genicon, Inc. II Mar-16-2018
12 Novadaq Technologies Inc. II Mar-02-2016
13 Olympus Corporation of the Americas II Apr-22-2020
14 Pentax Medical Company II Jul-23-2016
15 Pentax Medical Company II Jun-28-2016
16 Sharp Medical Products II Apr-06-2021
17 Stryker Corporation II Apr-15-2021
18 Stryker Corporation II Mar-02-2018
19 Teleflex Medical II Oct-07-2016
20 US Endoscopy Group Inc III Mar-08-2017
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