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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
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED SURGICAL CONCEPTS LTD
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ARK SURGICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHEX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASCLEPION LASER TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORTATION
  SUBSTANTIALLY EQUIVALENT 1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CHANGZHOU ANKANG MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLEARCAM, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
DANNIK
  SUBSTANTIALLY EQUIVALENT 2
EIZO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ELMED INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ENLIGHTENVUE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
GUANGZHOU TK MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUMAN XTENSIONS LTD.
  SUBSTANTIALLY EQUIVALENT 5
HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INCORE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
JIANGSU CHANNEL MEDICAL DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY-AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAZURITE HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
LIVSMED INC.
  SUBSTANTIALLY EQUIVALENT 1
LSI SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MAQUET CARDIOVASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDEON BIODESIGN, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDEON BIODESIGN, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICONCEPTS TECHNOLOGY (SHENZHEN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
NDS SURGICAL IMAGING, LLC.
  SUBSTANTIALLY EQUIVALENT 1
NEW VIEW SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
OMEC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLASMATICA LTD
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
PROGRESSIVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
REGER MEDIZINTECHNIK, GMBH
  SUBSTANTIALLY EQUIVALENT 1
SANTA BARBARA IMAGING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SCHOELLY FIBEROPTIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIDAM S.R.L
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SONY ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 2
STRYKER
  SUBSTANTIALLY EQUIVALENT 13
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 4
SURGICAL INNOVATIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD
  SUBSTANTIALLY EQUIVALENT 2
TAIWAN SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THERMASOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
UNIMAX MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
US MEDICAL INNOVATIONS, LLC
  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 2
XIMEDICA
  SUBSTANTIALLY EQUIVALENT 1
XPAN INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2578 2578
2020 2620 2620
2021 3430 3430
2022 3945 3945
2023 6005 6005
2024 517 517

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 3279 3279
Break 2550 2550
Detachment of Device or Device Component 2542 2542
Inflation Problem 1073 1073
Poor Quality Image 1063 1063
Material Split, Cut or Torn 1038 1038
Communication or Transmission Problem 868 868
Leak/Splash 750 750
Packaging Problem 733 733
Peeled/Delaminated 723 723
Material Fragmentation 592 592
Adverse Event Without Identified Device or Use Problem 511 511
Crack 431 431
Display or Visual Feedback Problem 339 339
Mechanical Problem 336 336
Image Orientation Incorrect 276 276
Fluid/Blood Leak 267 267
Loss of or Failure to Bond 256 256
Erratic or Intermittent Display 228 228
Decrease in Pressure 221 221
Difficult to Remove 215 215
Failure to Fire 213 213
Difficult to Insert 204 204
Output Problem 198 198
Insufficient Information 196 196
Material Integrity Problem 184 184
Material Rupture 177 177
Material Separation 166 166
Image Display Error/Artifact 166 166
Optical Problem 161 161
Gas/Air Leak 152 152
Positioning Failure 129 129
Corroded 128 128
Unintended System Motion 128 128
Noise, Audible 128 128
Device Contaminated During Manufacture or Shipping 120 120
Electrical /Electronic Property Problem 115 115
Overheating of Device 106 106
Fracture 99 99
Mechanics Altered 96 96
Premature Separation 94 94
Mechanical Jam 93 93
Product Quality Problem 89 89
Delivered as Unsterile Product 81 81
Component Missing 80 80
Failure to Power Up 75 75
Manufacturing, Packaging or Shipping Problem 75 75
Material Deformation 73 73
Device Slipped 73 73
Failure to Form Staple 71 71
Defective Device 68 68
Tear, Rip or Hole in Device Packaging 64 64
Sparking 62 62
Fogging 61 61
Entrapment of Device 61 61
Physical Resistance/Sticking 59 59
Material Twisted/Bent 58 58
Contamination /Decontamination Problem 57 57
Difficult to Open or Close 56 56
Appropriate Term/Code Not Available 54 54
Device Markings/Labelling Problem 52 52
Use of Device Problem 50 50
Device Contamination with Chemical or Other Material 48 48
Human-Device Interface Problem 47 47
Degraded 46 46
Connection Problem 45 45
Smoking 44 44
Component or Accessory Incompatibility 41 41
Defective Component 39 39
Burst Container or Vessel 37 37
Melted 37 37
Misfire 36 36
Temperature Problem 34 34
Patient Device Interaction Problem 32 32
Device Fell 32 32
Signal Artifact/Noise 32 32
Thermal Decomposition of Device 30 30
Loose or Intermittent Connection 30 30
Application Program Problem 30 30
Device Difficult to Setup or Prepare 30 30
Device Dislodged or Dislocated 30 30
Material Puncture/Hole 29 29
Retraction Problem 28 28
No Device Output 28 28
Arcing 27 27
Unintended Movement 27 27
Optical Distortion 27 27
Electrical Shorting 26 26
Unexpected Shutdown 26 26
Optical Discoloration 21 21
Power Problem 21 21
Disconnection 21 21
Fire 20 20
Self-Activation or Keying 20 20
No Apparent Adverse Event 20 20
Loss of Power 18 18
Arcing of Electrodes 18 18
Device Alarm System 18 18
Contamination 18 18
Intermittent Continuity 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12849 12849
No Consequences Or Impact To Patient 3147 3147
Insufficient Information 1141 1141
No Known Impact Or Consequence To Patient 940 940
No Patient Involvement 426 426
Foreign Body In Patient 327 327
No Information 217 217
No Code Available 173 173
Unspecified Tissue Injury 152 152
Hemorrhage/Bleeding 110 110
Device Embedded In Tissue or Plaque 67 67
Injury 49 49
Tissue Damage 47 47
Failure to Anastomose 45 45
Peritoneal Laceration(s) 38 38
Burn(s) 35 35
Pain 33 33
Hernia 33 33
Blood Loss 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Unspecified Infection 32 32
Hematoma 27 27
Patient Problem/Medical Problem 25 25
Seroma 24 24
Laceration(s) 23 23
Superficial (First Degree) Burn 23 23
Bowel Perforation 23 23
Post Operative Wound Infection 22 22
Obstruction/Occlusion 21 21
Unintended Radiation Exposure 21 21
Death 20 20
Abscess 18 18
Abdominal Pain 18 18
Burn, Thermal 18 18
Radiation Exposure, Unintended 16 16
Electric Shock 15 15
Tissue Breakdown 15 15
Fistula 14 14
Peritonitis 13 13
Urinary Retention 9 9
Perforation 9 9
Dysphagia/ Odynophagia 8 8
Wound Dehiscence 8 8
Adhesion(s) 8 8
Fever 7 7
Sepsis 6 6
Great Vessel Perforation 5 5
Unspecified Gastrointestinal Problem 5 5
Necrosis 5 5
Low Blood Pressure/ Hypotension 5 5
Bowel Burn 5 5
Exsanguination 5 5
Foreign Body Reaction 4 4
Abrasion 4 4
Anemia 4 4
Inflammation 4 4
Internal Organ Perforation 4 4
Pneumothorax 4 4
Unspecified Hepatic or Biliary Problem 4 4
Not Applicable 4 4
Rupture 4 4
Perforation of Vessels 4 4
Impaired Healing 4 4
Swelling/ Edema 4 4
Constipation 4 4
Stenosis 3 3
Discomfort 3 3
Complaint, Ill-Defined 3 3
Vomiting 3 3
Partial thickness (Second Degree) Burn 3 3
Cancer 3 3
Thrombosis/Thrombus 3 3
Shock 3 3
Skin Irritation 3 3
Nausea 3 3
Incontinence 3 3
Nerve Damage 3 3
Liver Laceration(s) 3 3
Pulmonary Embolism 3 3
Cardiac Arrest 3 3
Bruise/Contusion 3 3
Pulmonary Emphysema 2 2
Erythema 2 2
Exposure to Body Fluids 2 2
Erosion 2 2
Undesired Nerve Stimulation 2 2
Occlusion 2 2
Hypovolemic Shock 2 2
Phlebitis 2 2
Pneumonia 2 2
Shock from Patient Lead(s) 2 2
Urinary Tract Infection 2 2
Inadequate Pain Relief 2 2
Prolapse 2 2
Unspecified Respiratory Problem 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Intra-Abdominal Hemorrhage 1 1
Stenosis of the esophagus 1 1
Syncope/Fainting 1 1
Unspecified Nervous System Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Jul-11-2019
2 Baxter Healthcare Corporation II Jul-26-2021
3 Conmed Corporation II May-09-2019
4 CooperSurgical, Inc. II Feb-05-2024
5 Covidien LP II Apr-26-2023
6 Covidien, LP II Apr-12-2023
7 Davol, Inc. II Jul-22-2022
8 Davol, Inc. II Jun-30-2022
9 Genicon, Inc. II May-14-2020
10 Olympus Corporation of the Americas II Apr-22-2020
11 Sharp Medical Products II Apr-06-2021
12 Stryker Corporation II Mar-07-2022
13 Stryker Corporation II Apr-15-2021
14 Surgical Innovations Ltd II Jul-18-2022
15 Surgical Innovations Ltd II May-17-2023
16 Surgical Innovations Ltd II Sep-29-2022
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