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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
ARTHEX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCLEPION LASER TECHNOLOGIES GMBH
  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 4
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
DANNIK
  SUBSTANTIALLY EQUIVALENT 2
ELMED INCORPORATED
  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
GENICON, INC
  SUBSTANTIALLY EQUIVALENT 3
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
GUANGZHOU TK MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUMAN EXTENSION LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUMAN XTENSIONS LTD.
  SUBSTANTIALLY EQUIVALENT 3
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
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
LAZURITE HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
LEXINGTON MEDICAL INC.
  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 1
MEDEON BIODESIGN, INC.
  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
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
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 3
STRYKER
  SUBSTANTIALLY EQUIVALENT 14
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INNOVATIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
SYMMETRY SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
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
XODUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2562 2562
2019 2578 2578
2020 2620 2620
2021 3430 3430
2022 3947 3947
2023 723 723

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 2438 2438
Break 2434 2434
Detachment of Device or Device Component 1943 1943
Inflation Problem 1169 1169
Packaging Problem 919 919
Poor Quality Image 716 716
Leak/Splash 653 653
Material Split, Cut or Torn 638 638
Communication or Transmission Problem 570 570
Adverse Event Without Identified Device or Use Problem 448 448
Material Fragmentation 445 445
Peeled/Delaminated 354 354
Mechanical Problem 309 309
Crack 280 280
Difficult to Insert 268 268
Fluid/Blood Leak 257 257
Difficult to Remove 237 237
Detachment Of Device Component 232 232
Display or Visual Feedback Problem 224 224
Loss of or Failure to Bond 216 216
Failure to Fire 203 203
Material Rupture 186 186
Erratic or Intermittent Display 178 178
Material Separation 172 172
Gas/Air Leak 166 166
Insufficient Information 152 152
Material Integrity Problem 149 149
Noise, Audible 134 134
Optical Problem 129 129
Image Display Error/Artifact 124 124
Corroded 116 116
Mechanics Altered 113 113
Decrease in Pressure 110 110
Fracture 108 108
Output Problem 107 107
Overheating of Device 103 103
Electrical /Electronic Property Problem 99 99
Positioning Failure 93 93
Mechanical Jam 93 93
Premature Separation 86 86
Delivered as Unsterile Product 78 78
Device Slipped 73 73
Device Packaging Compromised 73 73
Material Deformation 72 72
Device Contaminated During Manufacture or Shipping 70 70
Contamination /Decontamination Problem 70 70
Component Missing 70 70
Tear, Rip or Hole in Device Packaging 69 69
Device Contamination with Chemical or Other Material 69 69
Failure to Form Staple 68 68
Product Quality Problem 68 68
Burst Container or Vessel 63 63
Manufacturing, Packaging or Shipping Problem 63 63
Physical Resistance/Sticking 61 61
Failure to Power Up 61 61
Material Twisted/Bent 56 56
Difficult to Open or Close 56 56
Sparking 55 55
Human-Device Interface Problem 54 54
Image Orientation Incorrect 52 52
Entrapment of Device 51 51
Defective Device 50 50
Use of Device Problem 49 49
Melted 45 45
Smoking 44 44
Device Fell 43 43
Misfire 40 40
Device Markings/Labelling Problem 38 38
Appropriate Term/Code Not Available 38 38
Torn Material 37 37
Electrical Shorting 37 37
Unintended System Motion 36 36
Thermal Decomposition of Device 35 35
Component or Accessory Incompatibility 35 35
Material Puncture/Hole 32 32
Degraded 30 30
Connection Problem 30 30
Application Program Problem 30 30
Retraction Problem 29 29
Activation, Positioning or Separation Problem 27 27
Device Operates Differently Than Expected 27 27
Device Difficult to Setup or Prepare 26 26
Loss of Power 24 24
Device Dislodged or Dislocated 24 24
Arcing 23 23
Temperature Problem 23 23
Unexpected Shutdown 23 23
Defective Component 23 23
Failure To Adhere Or Bond 22 22
Sharp Edges 21 21
Patient Device Interaction Problem 20 20
Optical Distortion 20 20
Contamination 20 20
Deflation Problem 19 19
Fogging 19 19
Fire 18 18
Device Alarm System 18 18
Optical Discoloration 18 18
Protective Measures Problem 17 17
Arcing of Electrodes 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7546 7546
No Consequences Or Impact To Patient 3685 3685
No Known Impact Or Consequence To Patient 2583 2583
Insufficient Information 766 766
No Patient Involvement 553 553
No Code Available 280 280
Foreign Body In Patient 279 279
No Information 264 264
Unspecified Tissue Injury 126 126
Device Embedded In Tissue or Plaque 96 96
Injury 81 81
Hemorrhage/Bleeding 79 79
Tissue Damage 74 74
Blood Loss 52 52
Failure to Anastomose 46 46
Pain 42 42
Peritoneal Laceration(s) 37 37
Unspecified Infection 35 35
Burn(s) 35 35
Hernia 34 34
Death 31 31
Burn, Thermal 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Hematoma 28 28
Seroma 26 26
Abdominal Pain 25 25
Patient Problem/Medical Problem 25 25
Radiation Exposure, Unintended 25 25
Post Operative Wound Infection 23 23
Obstruction/Occlusion 20 20
Abscess 20 20
Superficial (First Degree) Burn 18 18
Bowel Perforation 16 16
Laceration(s) 16 16
Electric Shock 15 15
Fistula 14 14
Peritonitis 13 13
Unintended Radiation Exposure 13 13
Urinary Retention 10 10
Adhesion(s) 10 10
Fever 7 7
Not Applicable 7 7
Cancer 7 7
Inflammation 6 6
Perforation 5 5
Exsanguination 5 5
Erythema 4 4
Wound Dehiscence 4 4
Internal Organ Perforation 4 4
Sepsis 4 4
Necrosis 4 4
Nerve Damage 4 4
Unspecified Gastrointestinal Problem 4 4
Unspecified Hepatic or Biliary Problem 4 4
Skin Irritation 4 4
Vomiting 4 4
Discomfort 4 4
Swelling/ Edema 4 4
Constipation 3 3
Complaint, Ill-Defined 3 3
Perforation of Vessels 3 3
Impaired Healing 3 3
Rupture 3 3
Urinary Tract Infection 3 3
Partial thickness (Second Degree) Burn 3 3
Vascular Dissection 3 3
Incontinence 3 3
Pneumothorax 3 3
Nausea 3 3
Abrasion 3 3
Pulmonary Embolism 3 3
Bruise/Contusion 3 3
Bowel Burn 3 3
Foreign Body Reaction 3 3
Pulmonary Emphysema 2 2
Erosion 2 2
Cardiac Arrest 2 2
Anemia 2 2
Occlusion 2 2
Phlebitis 2 2
Pneumonia 2 2
Shock 2 2
Hemostasis 2 2
Low Blood Pressure/ Hypotension 2 2
Shock from Patient Lead(s) 2 2
Prolapse 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Missing Value Reason 2 2
Swelling 2 2
Cardiac Tamponade 2 2
Burning Sensation 2 2
Inadequate Pain Relief 2 2
Depression 2 2
Blurred Vision 2 2
Stenosis 2 2
Unspecified Respiratory Problem 2 2
Unspecified Nervous System Problem 1 1
Ulcer 1 1
Cardiogenic Shock 1 1
Tooth Fracture 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 Davol, Inc. II Jul-22-2022
5 Davol, Inc. II Jun-30-2022
6 Espiner Medical Ltd II Nov-10-2018
7 Ethicon Endo-Surgery Inc II May-15-2018
8 Genicon, Inc. II May-14-2020
9 Genicon, Inc. II Mar-16-2018
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 Stryker Corporation II Mar-02-2018
15 Surgical Innovations Ltd II Jul-18-2022
16 Surgical Innovations Ltd II Sep-29-2022
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