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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
ARK SURGICAL, LTD.
  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 2
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
INCORE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
PLASMATICA LTD
  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 13
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 2557 2557

Device Problems MDRs with this Device Problem Events in those MDRs
Break 2993 2993
No Display/Image 2146 2146
Detachment of Device or Device Component 1767 1767
Inflation Problem 1466 1466
Packaging Problem 1010 1010
Detachment Of Device Component 874 874
Leak/Splash 716 716
Material Fragmentation 712 712
Poor Quality Image 607 607
Material Split, Cut or Torn 518 518
Adverse Event Without Identified Device or Use Problem 471 471
Communication or Transmission Problem 434 434
Difficult to Insert 319 319
Mechanical Problem 317 317
Difficult to Remove 274 274
Fluid Leak 253 253
Crack 237 237
Device Packaging Compromised 216 216
Failure to Fire 214 214
Peeled/Delaminated 207 207
Loss of or Failure to Bond 196 196
Gas Leak 193 193
Material Rupture 189 189
Material Separation 187 187
Display or Visual Feedback Problem 185 185
Mechanics Altered 184 184
Erratic or Intermittent Display 154 154
Noise, Audible 152 152
Fracture 141 141
Insufficient Information 138 138
Overheating of Device 126 126
Optical Problem 118 118
Material Integrity Problem 116 116
Mechanical Jam 114 114
Device Operates Differently Than Expected 109 109
Material Deformation 108 108
Corroded 108 108
Torn Material 107 107
Electrical /Electronic Property Problem 100 100
Image Display Error/Artifact 96 96
Decrease in Pressure 96 96
Device Contamination with Chemical or Other Material 85 85
Burst Container or Vessel 84 84
Positioning Failure 83 83
Activation, Positioning or SeparationProblem 79 79
Tear, Rip or Hole in Device Packaging 78 78
Failure to Form Staple 76 76
Electrical Shorting 76 76
Human-Device Interface Problem 75 75
Premature Separation 74 74
Output Problem 73 73
Delivered as Unsterile Product 72 72
Product Quality Problem 71 71
Device Slipped 69 69
Contamination /Decontamination Problem 69 69
Component Missing 68 68
Difficult to Open or Close 61 61
Sparking 60 60
Manufacturing, Packaging or Shipping Problem 59 59
Failure To Adhere Or Bond 59 59
Melted 57 57
Entrapment of Device 57 57
Physical Resistance/Sticking 56 56
Misfire 56 56
Failure to Power Up 55 55
Material Twisted/Bent 50 50
Defective Device 48 48
Device Contaminated During Manufacture or Shipping 46 46
Material Perforation 45 45
Smoking 45 45
Use of Device Problem 45 45
Thermal Decomposition of Device 41 41
Device Fell 41 41
Hole In Material 40 40
Component Falling 39 39
Retraction Problem 39 39
Appropriate Term/Code Not Available 39 39
Device Markings/Labelling Problem 39 39
Deflation Problem 37 37
Bent 37 37
Loss of Power 32 32
Material Puncture/Hole 31 31
Application Program Problem 30 30
Defective Component 29 29
Device Difficult to Setup or Prepare 28 28
Connection Problem 28 28
Temperature Problem 28 28
Device Dislodged or Dislocated 27 27
Physical Resistance 26 26
No Device Output 25 25
Failure to Advance 23 23
Unexpected Shutdown 23 23
Arcing 22 22
Fire 22 22
Air Leak 21 21
Component or Accessory Incompatibility 21 21
Sharp Edges 21 21
Fogging 20 20
Material Protrusion/Extrusion 19 19
Protective Measures Problem 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5628 5628
No Consequences Or Impact To Patient 4881 4881
No Known Impact Or Consequence To Patient 4460 4460
No Patient Involvement 622 622
Insufficient Information 599 599
No Information 393 393
No Code Available 334 334
Foreign Body In Patient 294 294
Device Embedded In Tissue or Plaque 132 132
Injury 110 110
Tissue Damage 101 101
Unspecified Tissue Injury 92 92
Hemorrhage/Bleeding 68 68
Blood Loss 64 64
Failure to Anastomose 48 48
Unspecified Infection 41 41
Pain 39 39
Burn(s) 39 39
Peritoneal Laceration(s) 37 37
Death 36 36
Burn, Thermal 36 36
Radiation Exposure, Unintended 36 36
Hernia 34 34
Patient Problem/Medical Problem 26 26
Post Operative Wound Infection 26 26
Hematoma 25 25
Abdominal Pain 22 22
Abscess 22 22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Laceration(s) 21 21
Obstruction/Occlusion 21 21
Seroma 21 21
Bowel Perforation 17 17
Not Applicable 15 15
Electric Shock 14 14
Fistula 14 14
Perforation 13 13
Superficial (First Degree) Burn 13 13
Peritonitis 13 13
Cancer 12 12
Unintended Radiation Exposure 10 10
Urinary Retention 9 9
Adhesion(s) 9 9
Fever 7 7
Inflammation 6 6
Discomfort 6 6
Partial thickness (Second Degree) Burn 5 5
Skin Irritation 5 5
Exsanguination 5 5
Pulmonary Emphysema 4 4
Cardiac Arrest 4 4
Abrasion 4 4
Wound Dehiscence 4 4
Bowel Burn 4 4
Sepsis 4 4
Internal Organ Perforation 4 4
Full thickness (Third Degree) Burn 4 4
Vomiting 4 4
Unspecified Gastrointestinal Problem 4 4
Unspecified Hepatic or Biliary Problem 4 4
Swelling/ Edema 3 3
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
Myocardial Infarction 3 3
Nausea 3 3
Necrosis 3 3
Bruise/Contusion 3 3
Pulmonary Embolism 3 3
Erythema 3 3
Foreign Body Reaction 2 2
Erosion 2 2
Nerve Damage 2 2
Occlusion 2 2
Hemostasis 2 2
Low Blood Pressure/ Hypotension 2 2
Pneumonia 2 2
Swelling 2 2
Phlebitis 2 2
Incontinence 2 2
Shock from Patient Lead(s) 2 2
Skin Tears 2 2
Prolapse 2 2
Inadequate Pain Relief 2 2
Ulcer 2 2
Numbness 2 2
Stenosis 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
Unspecified Respiratory Problem 2 2
Unspecified Kidney or Urinary Problem 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 Davol, Inc. II Jul-22-2022
8 Davol, Inc. II Jun-30-2022
9 Espiner Medical Ltd II Nov-10-2018
10 Ethicon Endo-Surgery Inc II May-15-2018
11 Genicon, Inc. II May-14-2020
12 Genicon, Inc. II Mar-16-2018
13 Olympus Corporation of the Americas II Apr-22-2020
14 Sharp Medical Products II Apr-06-2021
15 Stryker Corporation II Mar-07-2022
16 Stryker Corporation II Apr-15-2021
17 Stryker Corporation II Mar-02-2018
18 Surgical Innovations Ltd II Jul-18-2022
19 US Endoscopy Group Inc III Mar-08-2017
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