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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
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
ADVANCED MEDICAL DESIGN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED SURGICAL CONCEPTS LTD
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORTATION
  SUBSTANTIALLY EQUIVALENT 1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING HANGTIAN KADI TECHNOLOGY R&D INSTITUTE
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLEARCAM, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
DANNIK
  SUBSTANTIALLY EQUIVALENT 2
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELMED INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ENDOCLOT PLUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENLIGHTENVUE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FENGH MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM NEW DEVELOPMENT U.S.A., INC.
  SUBSTANTIALLY EQUIVALENT 2
GENICON, INC
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU TK MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUMAN EXTENSION LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUMAN XTENSIONS LTD.
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
LAZURITE HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
LEXINGTON MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
LIVSMED INC.
  SUBSTANTIALLY EQUIVALENT 1
LSI SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOVASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
MARINER ENDOSURGERY INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEON BIODESIGN, INC
  SUBSTANTIALLY EQUIVALENT 2
MEDEON BIODESIGN, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS INC. (D/B/A NORDSON MEDICAL)
  SUBSTANTIALLY EQUIVALENT 1
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NDS SURGICAL IMAGING, LLC.
  SUBSTANTIALLY EQUIVALENT 1
NEOSURGICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
NEW VIEW SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVADAQ TECHNOLOGIES ULC (NOW A PART OF STRYKER)
  SUBSTANTIALLY EQUIVALENT 1
NOVATECH S.A.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
OMEC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
PROGRESSIVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEJONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIDAM S.R.L
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONY ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 4
STRYKER
  SUBSTANTIALLY EQUIVALENT 10
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INNOVATIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SYMMETRY SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD.
  SUBSTANTIALLY EQUIVALENT 1
UNIMAX MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
WICKIMED(HUIZHOU)MEDICAL EQUIPMENT MANUFACTURING CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI SHUKANG MEDICAL APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XENOCOR, INC
  SUBSTANTIALLY EQUIVALENT 3
XODUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3467 3467
2018 2562 2562
2019 2578 2578
2020 2620 2620
2021 3430 3430
2022 1268 1268

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2837 2837
No Display/Image 1819 1819
Detachment of Device or Device Component 1676 1676
Inflation Problem 1408 1408
Packaging Problem 1009 1009
Detachment Of Device Component 874 874
Material Fragmentation 691 691
Leak/Splash 684 684
Poor Quality Image 527 527
Material Split, Cut or Torn 447 447
Adverse Event Without Identified Device or Use Problem 432 432
Communication or Transmission Problem 382 382
Difficult to Insert 312 312
Mechanical Problem 291 291
Difficult to Remove 265 265
Fluid Leak 240 240
Device Packaging Compromised 216 216
Crack 206 206
Failure to Fire 196 196
Material Rupture 185 185
Gas Leak 184 184
Material Separation 180 180
Loss of or Failure to Bond 179 179
Mechanics Altered 173 173
Noise, Audible 140 140
Display or Visual Feedback Problem 133 133
Fracture 132 132
Insufficient Information 125 125
Overheating of Device 124 124
Erratic or Intermittent Display 123 123
Device Operates Differently Than Expected 109 109
Optical Problem 108 108
Mechanical Jam 107 107
Torn Material 107 107
Material Integrity Problem 106 106
Material Deformation 104 104
Peeled/Delaminated 102 102
Corroded 98 98
Electrical /Electronic Property Problem 94 94
Decrease in Pressure 88 88
Device Contamination with Chemical or Other Material 84 84
Burst Container or Vessel 83 83
Activation, Positioning or SeparationProblem 79 79
Tear, Rip or Hole in Device Packaging 77 77
Image Display Error/Artifact 74 74
Failure to Form Staple 71 71
Premature Separation 70 70
Contamination /Decontamination Problem 69 69
Human-Device Interface Problem 69 69
Electrical Shorting 69 69
Product Quality Problem 67 67
Positioning Failure 66 66
Delivered as Unsterile Product 65 65
Component Missing 65 65
Device Slipped 63 63
Failure To Adhere Or Bond 59 59
Output Problem 58 58
Difficult to Open or Close 54 54
Misfire 54 54
Sparking 52 52
Manufacturing, Packaging or Shipping Problem 52 52
Entrapment of Device 52 52
Melted 51 51
Failure to Power Up 50 50
Material Twisted/Bent 47 47
Physical Resistance/Sticking 47 47
Defective Device 46 46
Material Perforation 45 45
Smoking 43 43
Device Fell 41 41
Use of Device Problem 40 40
Hole In Material 40 40
Thermal Decomposition of Device 40 40
Component Falling 39 39
Appropriate Term/Code Not Available 39 39
Deflation Problem 37 37
Bent 37 37
Device Markings/Labelling Problem 36 36
Device Contaminated During Manufacture or Shipping 35 35
Retraction Problem 31 31
Application Program Problem 29 29
Loss of Power 28 28
Material Puncture/Hole 27 27
Defective Component 27 27
Device Difficult to Setup or Prepare 26 26
Physical Resistance 26 26
Device Dislodged or Dislocated 26 26
Temperature Problem 24 24
Connection Problem 23 23
No Device Output 23 23
Failure to Advance 23 23
Unexpected Shutdown 22 22
Sharp Edges 21 21
Arcing 21 21
Air Leak 21 21
Fire 21 21
Fogging 20 20
Device Alarm System 18 18
Component or Accessory Incompatibility 18 18
Material Protrusion/Extrusion 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4881 4881
No Known Impact Or Consequence To Patient 4460 4460
No Clinical Signs, Symptoms or Conditions 4450 4450
No Patient Involvement 622 622
Insufficient Information 495 495
No Information 393 393
No Code Available 334 334
Foreign Body In Patient 273 273
Device Embedded In Tissue or Plaque 132 132
Injury 110 110
Tissue Damage 101 101
Unspecified Tissue Injury 75 75
Blood Loss 64 64
Hemorrhage/Bleeding 59 59
Failure to Anastomose 45 45
Unspecified Infection 39 39
Pain 39 39
Burn(s) 36 36
Death 36 36
Burn, Thermal 36 36
Radiation Exposure, Unintended 36 36
Peritoneal Laceration(s) 33 33
Hernia 29 29
Patient Problem/Medical Problem 26 26
Post Operative Wound Infection 25 25
Hematoma 24 24
Seroma 21 21
Obstruction/Occlusion 20 20
Abdominal Pain 20 20
Abscess 19 19
Laceration(s) 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Bowel Perforation 15 15
Not Applicable 15 15
Perforation 13 13
Fistula 13 13
Superficial (First Degree) Burn 12 12
Electric Shock 12 12
Peritonitis 12 12
Cancer 11 11
Urinary Retention 9 9
Unintended Radiation Exposure 9 9
Adhesion(s) 8 8
Fever 7 7
Discomfort 6 6
Partial thickness (Second Degree) Burn 5 5
Skin Irritation 5 5
Inflammation 5 5
Exsanguination 5 5
Pulmonary Emphysema 4 4
Wound Dehiscence 4 4
Bowel Burn 4 4
Internal Organ Perforation 4 4
Full thickness (Third Degree) Burn 4 4
Sepsis 4 4
Vomiting 4 4
Unspecified Gastrointestinal Problem 4 4
Unspecified Hepatic or Biliary Problem 4 4
Rupture 3 3
Perforation of Vessels 3 3
Complaint, Ill-Defined 3 3
Impaired Healing 3 3
Vascular Dissection 3 3
Constipation 3 3
Missing Value Reason 3 3
Pneumothorax 3 3
Nausea 3 3
Necrosis 3 3
Pulmonary Embolism 3 3
Abrasion 3 3
Erythema 3 3
Cardiac Arrest 3 3
Foreign Body Reaction 2 2
Erosion 2 2
Bruise/Contusion 2 2
Nerve Damage 2 2
Occlusion 2 2
Hemostasis 2 2
Low Blood Pressure/ Hypotension 2 2
Incontinence 2 2
Swelling 2 2
Myocardial Infarction 2 2
Phlebitis 2 2
Unspecified Respiratory Problem 2 2
Shock from Patient Lead(s) 2 2
Prolapse 2 2
Numbness 2 2
Skin Tears 2 2
Inadequate Pain Relief 2 2
Ulcer 2 2
Blurred Vision 2 2
Shock 2 2
Urinary Tract Infection 2 2
Cardiac Tamponade 2 2
Excessive Tear Production 2 2
Burning Sensation 2 2
Swelling/ Edema 2 2
Genital Bleeding 1 1
Menorrhagia 1 1
Osteomyelitis 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 Baxter Healthcare Corporation II Jul-26-2021
4 Conmed Corporation II May-09-2019
5 Cook Inc. II Jun-08-2017
6 Covidien LLC II Jun-23-2017
7 Espiner Medical Ltd II Nov-10-2018
8 Ethicon Endo-Surgery Inc II May-15-2018
9 Genicon, Inc. II May-14-2020
10 Genicon, Inc. II Mar-16-2018
11 Olympus Corporation of the Americas II Apr-22-2020
12 Sharp Medical Products II Apr-06-2021
13 Stryker Corporation II Mar-07-2022
14 Stryker Corporation II Apr-15-2021
15 Stryker Corporation II Mar-02-2018
16 US Endoscopy Group Inc III Mar-08-2017
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