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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
HANGZHOU KANGJI 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 5
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
VEOL MEDICAL TECHNOLOGIES PVT 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 2
XIMEDICA
  SUBSTANTIALLY EQUIVALENT 2
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 1726 1726

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 3441 3441
Detachment of Device or Device Component 2700 2700
Break 2639 2639
Poor Quality Image 1202 1202
Material Split, Cut or Torn 1191 1191
Inflation Problem 1125 1125
Communication or Transmission Problem 919 919
Peeled/Delaminated 856 856
Leak/Splash 854 854
Packaging Problem 734 734
Material Fragmentation 608 608
Adverse Event Without Identified Device or Use Problem 533 533
Crack 446 446
Mechanical Problem 358 358
Display or Visual Feedback Problem 342 342
Image Orientation Incorrect 312 312
Fluid/Blood Leak 279 279
Loss of or Failure to Bond 257 257
Decrease in Pressure 242 242
Erratic or Intermittent Display 232 232
Failure to Fire 226 226
Insufficient Information 220 220
Difficult to Remove 215 215
Difficult to Insert 213 213
Output Problem 207 207
Material Integrity Problem 207 207
Material Rupture 177 177
Image Display Error/Artifact 175 175
Material Separation 169 169
Gas/Air Leak 166 166
Optical Problem 163 163
Unintended System Motion 135 135
Positioning Failure 135 135
Corroded 133 133
Noise, Audible 133 133
Device Contaminated During Manufacture or Shipping 122 122
Electrical /Electronic Property Problem 115 115
Overheating of Device 111 111
Fracture 103 103
Mechanics Altered 100 100
Premature Separation 100 100
Mechanical Jam 97 97
Product Quality Problem 94 94
Component Missing 86 86
Delivered as Unsterile Product 82 82
Failure to Power Up 80 80
Device Slipped 77 77
Manufacturing, Packaging or Shipping Problem 76 76
Material Deformation 76 76
Failure to Form Staple 74 74
Defective Device 69 69
Fogging 69 69
Entrapment of Device 66 66
Tear, Rip or Hole in Device Packaging 65 65
Sparking 62 62
Material Twisted/Bent 61 61
Physical Resistance/Sticking 60 60
Difficult to Open or Close 58 58
Contamination /Decontamination Problem 57 57
Appropriate Term/Code Not Available 54 54
Device Markings/Labelling Problem 52 52
Use of Device Problem 51 51
Degraded 51 51
Device Contamination with Chemical or Other Material 50 50
Connection Problem 48 48
Human-Device Interface Problem 47 47
Smoking 45 45
Component or Accessory Incompatibility 44 44
Defective Component 41 41
Melted 38 38
Signal Artifact/Noise 37 37
Burst Container or Vessel 37 37
Temperature Problem 37 37
Loose or Intermittent Connection 36 36
Misfire 36 36
Thermal Decomposition of Device 33 33
Patient Device Interaction Problem 33 33
Device Fell 32 32
No Device Output 31 31
Application Program Problem 31 31
Device Difficult to Setup or Prepare 31 31
Material Puncture/Hole 31 31
Device Dislodged or Dislocated 30 30
Unintended Movement 29 29
Retraction Problem 29 29
Electrical Shorting 28 28
Optical Distortion 27 27
Unexpected Shutdown 27 27
Arcing 27 27
Disconnection 22 22
Optical Discoloration 21 21
Power Problem 21 21
Protective Measures Problem 20 20
No Apparent Adverse Event 20 20
Fire 20 20
Arcing of Electrodes 20 20
Self-Activation or Keying 20 20
Loss of Power 19 19
Failure to Clean Adequately 19 19
Loss of Data 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13969 13969
No Consequences Or Impact To Patient 3147 3147
Insufficient Information 1220 1220
No Known Impact Or Consequence To Patient 940 940
No Patient Involvement 426 426
Foreign Body In Patient 335 335
No Information 217 217
No Code Available 173 173
Unspecified Tissue Injury 156 156
Hemorrhage/Bleeding 122 122
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
Unspecified Infection 37 37
Burn(s) 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Pain 33 33
Hernia 33 33
Blood Loss 33 33
Laceration(s) 29 29
Hematoma 27 27
Patient Problem/Medical Problem 25 25
Bowel Perforation 24 24
Seroma 24 24
Superficial (First Degree) Burn 23 23
Post Operative Wound Infection 22 22
Unintended Radiation Exposure 22 22
Obstruction/Occlusion 21 21
Tissue Breakdown 20 20
Death 20 20
Abscess 19 19
Abdominal Pain 18 18
Burn, Thermal 18 18
Electric Shock 17 17
Radiation Exposure, Unintended 16 16
Fistula 14 14
Peritonitis 13 13
Urinary Retention 10 10
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
Liver Laceration(s) 5 5
Necrosis 5 5
Low Blood Pressure/ Hypotension 5 5
Cardiac Arrest 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
Pulmonary Embolism 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
Burning Sensation 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

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Inc II Mar-01-2024
2 Applied Medical Resources Corp II Jul-11-2019
3 Baxter Healthcare Corporation II Jul-26-2021
4 Conmed Corporation II May-09-2019
5 CooperSurgical, Inc. II Feb-05-2024
6 Covidien LP II Apr-26-2023
7 Covidien, LP II Apr-03-2024
8 Covidien, LP II Apr-12-2023
9 Davol, Inc. II Jul-22-2022
10 Davol, Inc. II Jun-30-2022
11 Genicon, Inc. II May-14-2020
12 Olympus Corporation of the Americas II Apr-22-2020
13 Sharp Medical Products II Apr-06-2021
14 Stryker Corporation II Mar-07-2022
15 Stryker Corporation II Apr-15-2021
16 Surgical Innovations Ltd II Jul-18-2022
17 Surgical Innovations Ltd II May-17-2023
18 Surgical Innovations Ltd II Sep-29-2022
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