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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
M/S. MERIL ENDO SURGERY PRIVATE LIMITED.
  SUBSTANTIALLY EQUIVALENT 1
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
MICROMEDICS, INC.
  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 2
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
YUWONMEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI DIPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 2578 2578
2020 2620 2620
2021 3430 3430
2022 3945 3945
2023 6005 6005
2024 3362 3362

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 3665 3665
Detachment of Device or Device Component 2855 2855
Break 2838 2838
Poor Quality Image 1358 1358
Material Split, Cut or Torn 1338 1338
Inflation Problem 1204 1204
Peeled/Delaminated 1030 1030
Communication or Transmission Problem 1008 1008
Leak/Splash 954 954
Packaging Problem 736 736
Material Fragmentation 652 652
Adverse Event Without Identified Device or Use Problem 564 564
Crack 472 472
Mechanical Problem 385 385
Display or Visual Feedback Problem 370 370
Image Orientation Incorrect 348 348
Fluid/Blood Leak 288 288
Loss of or Failure to Bond 269 269
Decrease in Pressure 262 262
Erratic or Intermittent Display 244 244
Insufficient Information 239 239
Failure to Fire 233 233
Material Integrity Problem 225 225
Output Problem 223 223
Difficult to Insert 223 223
Difficult to Remove 216 216
Gas/Air Leak 194 194
Image Display Error/Artifact 185 185
Material Rupture 177 177
Material Separation 174 174
Optical Problem 169 169
Noise, Audible 156 156
Positioning Failure 143 143
Unintended System Motion 139 139
Corroded 135 135
Overheating of Device 126 126
Device Contaminated During Manufacture or Shipping 123 123
Electrical /Electronic Property Problem 117 117
Premature Separation 107 107
Fracture 105 105
Mechanics Altered 104 104
Product Quality Problem 101 101
Mechanical Jam 100 100
Failure to Power Up 99 99
Component Missing 95 95
Delivered as Unsterile Product 83 83
Defective Device 82 82
Device Slipped 82 82
Material Deformation 81 81
Manufacturing, Packaging or Shipping Problem 77 77
Failure to Form Staple 75 75
Fogging 72 72
Entrapment of Device 66 66
Tear, Rip or Hole in Device Packaging 66 66
Sparking 65 65
Material Twisted/Bent 65 65
Connection Problem 62 62
Physical Resistance/Sticking 60 60
Degraded 60 60
Difficult to Open or Close 58 58
Contamination /Decontamination Problem 57 57
Appropriate Term/Code Not Available 57 57
Use of Device Problem 55 55
Device Markings/Labelling Problem 54 54
Human-Device Interface Problem 53 53
Device Contamination with Chemical or Other Material 52 52
Component or Accessory Incompatibility 51 51
Smoking 48 48
Loose or Intermittent Connection 48 48
Temperature Problem 46 46
Defective Component 43 43
Melted 41 41
Signal Artifact/Noise 40 40
Burst Container or Vessel 37 37
Thermal Decomposition of Device 36 36
Misfire 36 36
Material Puncture/Hole 36 36
Device Difficult to Setup or Prepare 34 34
Device Fell 34 34
Patient Device Interaction Problem 34 34
Application Program Problem 32 32
No Device Output 32 32
Retraction Problem 30 30
Unexpected Shutdown 30 30
Unintended Movement 30 30
Device Dislodged or Dislocated 30 30
Electrical Shorting 28 28
Optical Distortion 28 28
Arcing 28 28
Disconnection 24 24
Arcing of Electrodes 23 23
Optical Discoloration 22 22
Failure to Clean Adequately 22 22
Power Problem 21 21
Fire 21 21
Self-Activation or Keying 20 20
Loss of Power 20 20
Protective Measures Problem 20 20
No Apparent Adverse Event 20 20
Loss of Data 20 20

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15469 15469
No Consequences Or Impact To Patient 3147 3147
Insufficient Information 1297 1297
No Known Impact Or Consequence To Patient 940 940
No Patient Involvement 426 426
Foreign Body In Patient 365 365
No Information 217 217
No Code Available 173 173
Unspecified Tissue Injury 165 165
Hemorrhage/Bleeding 131 131
Device Embedded In Tissue or Plaque 67 67
Injury 49 49
Tissue Damage 47 47
Failure to Anastomose 45 45
Burn(s) 39 39
Unspecified Infection 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Peritoneal Laceration(s) 38 38
Pain 36 36
Laceration(s) 34 34
Hernia 34 34
Blood Loss 33 33
Tissue Breakdown 29 29
Bowel Perforation 27 27
Hematoma 27 27
Superficial (First Degree) Burn 26 26
Patient Problem/Medical Problem 25 25
Seroma 24 24
Unintended Radiation Exposure 24 24
Post Operative Wound Infection 22 22
Obstruction/Occlusion 21 21
Death 20 20
Abscess 19 19
Abdominal Pain 18 18
Burn, Thermal 18 18
Electric Shock 17 17
Radiation Exposure, Unintended 16 16
Urinary Retention 16 16
Perforation 14 14
Fistula 14 14
Peritonitis 13 13
Fever 11 11
Dysphagia/ Odynophagia 8 8
Wound Dehiscence 8 8
Adhesion(s) 8 8
Pulmonary Emphysema 6 6
Liver Laceration(s) 6 6
Stenosis 6 6
Sepsis 6 6
Urinary Incontinence 6 6
Urethral Stenosis/Stricture 5 5
Unspecified Gastrointestinal Problem 5 5
Great Vessel Perforation 5 5
Urinary Tract Infection 5 5
Inflammation 5 5
Low Blood Pressure/ Hypotension 5 5
Necrosis 5 5
Pneumothorax 5 5
Exsanguination 5 5
Cardiac Arrest 5 5
Abrasion 5 5
Bowel Burn 5 5
Anemia 4 4
Foreign Body Reaction 4 4
Internal Organ Perforation 4 4
Perforation of Vessels 4 4
Rupture 4 4
Impaired Healing 4 4
Not Applicable 4 4
Constipation 4 4
Hematuria 4 4
Unspecified Hepatic or Biliary Problem 4 4
Swelling/ Edema 4 4
Cancer 3 3
Thrombosis/Thrombus 3 3
Partial thickness (Second Degree) Burn 3 3
Discomfort 3 3
Complaint, Ill-Defined 3 3
Vomiting 3 3
Shock 3 3
Skin Irritation 3 3
Nausea 3 3
Nerve Damage 3 3
Incontinence 3 3
Bruise/Contusion 3 3
Pulmonary Embolism 3 3
Exposure to Body Fluids 2 2
Erosion 2 2
Erythema 2 2
Hypothermia 2 2
Hypovolemic Shock 2 2
Undesired Nerve Stimulation 2 2
Occlusion 2 2
Phlebitis 2 2
Pleural Effusion 2 2
Pneumonia 2 2
Burning Sensation 2 2
Malaise 2 2
Inadequate Pain Relief 2 2
Shock from Patient Lead(s) 2 2

Recalls
Manufacturer Recall Class Date Posted
1 ASPEN SURGICAL II Jun-27-2024
2 Aesculap Inc II Mar-01-2024
3 Applied Medical Resources Corp II Jul-11-2019
4 Baxter Healthcare Corporation II Jul-26-2021
5 Canadian Hospital Specialties Ltd. II Jul-17-2024
6 Conmed Corporation II May-09-2019
7 CooperSurgical, Inc. II Feb-05-2024
8 Covidien LP II Apr-26-2023
9 Covidien, LP II Apr-03-2024
10 Covidien, LP II Apr-12-2023
11 Davol, Inc. II Jul-22-2022
12 Davol, Inc. II Jun-30-2022
13 Genicon, Inc. II May-14-2020
14 Olympus Corporation of the Americas II Apr-22-2020
15 Sharp Medical Products II Apr-06-2021
16 Stryker Corporation II Mar-07-2022
17 Stryker Corporation II Apr-15-2021
18 Surgical Innovations Ltd II Jul-18-2022
19 Surgical Innovations Ltd II May-17-2023
20 Surgical Innovations Ltd II Sep-29-2022
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