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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
ADVAMEDIX, GMBH
  SUBSTANTIALLY EQUIVALENT 2
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 3
ASCLEPION LASER TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 2
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 5
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 OPERATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
LAGIS ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LAZURITE HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS INC.
  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
OUI 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 6
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
TROCARE, 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 5678 5678

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 4016 4016
Detachment of Device or Device Component 3162 3162
Break 3161 3161
Poor Quality Image 1553 1553
Material Split, Cut or Torn 1470 1470
Inflation Problem 1365 1365
Peeled/Delaminated 1227 1227
Communication or Transmission Problem 1124 1124
Leak/Splash 1051 1051
Packaging Problem 738 738
Material Fragmentation 730 730
Adverse Event Without Identified Device or Use Problem 592 592
Crack 531 531
Image Orientation Incorrect 418 418
Mechanical Problem 408 408
Display or Visual Feedback Problem 405 405
Decrease in Pressure 292 292
Fluid/Blood Leak 289 289
Loss of or Failure to Bond 273 273
Erratic or Intermittent Display 271 271
Insufficient Information 266 266
Material Integrity Problem 258 258
Output Problem 258 258
Failure to Fire 242 242
Gas/Air Leak 236 236
Difficult to Insert 233 233
Difficult to Remove 220 220
Optical Problem 201 201
Image Display Error/Artifact 197 197
Material Rupture 184 184
Material Separation 179 179
Noise, Audible 174 174
Positioning Failure 150 150
Unintended System Motion 143 143
Corroded 141 141
Device Contaminated During Manufacture or Shipping 130 130
Overheating of Device 129 129
Failure to Power Up 124 124
Electrical /Electronic Property Problem 119 119
Premature Separation 110 110
Fracture 109 109
Mechanics Altered 107 107
Mechanical Jam 104 104
Product Quality Problem 102 102
Component Missing 98 98
Device Slipped 93 93
Delivered as Unsterile Product 91 91
Connection Problem 87 87
Defective Device 87 87
Material Deformation 87 87

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 17606 17606
No Consequences Or Impact To Patient 3147 3147
Insufficient Information 1395 1395
No Known Impact Or Consequence To Patient 940 940
No Patient Involvement 426 426
Foreign Body In Patient 403 403
No Information 217 217
Unspecified Tissue Injury 177 177
No Code Available 173 173
Hemorrhage/Bleeding 152 152
Device Embedded In Tissue or Plaque 69 69
Injury 49 49
Tissue Damage 47 47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 46 46
Failure to Anastomose 46 46
Pain 45 45
Unspecified Infection 43 43
Burn(s) 41 41
Laceration(s) 39 39
Peritoneal Laceration(s) 38 38
Hernia 38 38
Tissue Breakdown 36 36
Blood Loss 33 33
Bowel Perforation 29 29
Hematoma 28 28
Unintended Radiation Exposure 27 27
Superficial (First Degree) Burn 27 27
Seroma 27 27
Patient Problem/Medical Problem 25 25
Obstruction/Occlusion 25 25
Post Operative Wound Infection 23 23
Abscess 22 22
Death 20 20
Abdominal Pain 19 19
Burn, Thermal 18 18
Electric Shock 17 17
Radiation Exposure, Unintended 16 16
Perforation 15 15
Urinary Retention 15 15
Fistula 14 14
Peritonitis 13 13
Liver Laceration(s) 13 13
Sepsis 11 11
Fever 11 11
Urinary Tract Infection 9 9
Dysphagia/ Odynophagia 8 8
Adhesion(s) 8 8
Wound Dehiscence 8 8
Necrosis 7 7
Hematuria 6 6

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 Carefusion 2200 Inc II Sep-30-2024
7 Conmed Corporation II May-09-2019
8 CooperSurgical, Inc. II Feb-05-2024
9 Covidien LP II Apr-26-2023
10 Covidien, LP II Apr-03-2024
11 Covidien, LP II Apr-12-2023
12 Davol, Inc. II Jul-22-2022
13 Davol, Inc. II Jun-30-2022
14 Genicon, Inc. II May-14-2020
15 Olympus Corporation of the Americas II Apr-22-2020
16 Sharp Medical Products II Apr-06-2021
17 Stryker Corporation II Mar-07-2022
18 Stryker Corporation II Apr-15-2021
19 Surgical Innovations Ltd II Jul-18-2022
20 Surgical Innovations Ltd II May-17-2023
21 Surgical Innovations Ltd II Sep-29-2022
22 UNIMAX MEDICAL SYSTEMS INC II Sep-17-2024
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