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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
Regulation Description Endoscope and accessories.
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 5
ASCLEPION LASER TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 2
BARCO NV
  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
DANNIK, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 2
LAZURITE HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 3
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 3431 3431
2022 3945 3945
2023 6005 6005
2024 6048 6048
2025 2234 2234

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 4307 4307
Break 3518 3518
Detachment of Device or Device Component 3476 3476
Poor Quality Image 1753 1753
Material Split, Cut or Torn 1614 1614
Inflation Problem 1515 1515
Peeled/Delaminated 1269 1269
Communication or Transmission Problem 1266 1266
Leak/Splash 1124 1124
Material Fragmentation 828 828
Packaging Problem 738 738
Adverse Event Without Identified Device or Use Problem 613 613
Crack 609 609
Image Orientation Incorrect 496 496
Display or Visual Feedback Problem 486 486
Mechanical Problem 443 443
Loss of or Failure to Bond 325 325
Erratic or Intermittent Display 325 325
Decrease in Pressure 323 323
Fluid/Blood Leak 307 307
Gas/Air Leak 291 291
Material Integrity Problem 289 289
Output Problem 287 287
Insufficient Information 281 281
Failure to Fire 268 268
Difficult to Insert 252 252
Optical Problem 249 249
Difficult to Remove 226 226
Material Separation 202 202
Image Display Error/Artifact 202 202
Material Rupture 188 188
Noise, Audible 187 187
Positioning Failure 160 160
Unintended System Motion 148 148
Corroded 146 146
Device Contaminated During Manufacture or Shipping 144 144
Overheating of Device 143 143
Failure to Power Up 142 142
Fracture 140 140
Connection Problem 126 126
Premature Separation 123 123
Electrical /Electronic Property Problem 123 123
Product Quality Problem 115 115
Mechanics Altered 110 110
Temperature Problem 106 106
Mechanical Jam 106 106
Component Missing 103 103
Smoking 101 101
Device Slipped 101 101
Material Deformation 100 100

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19937 19937
No Consequences Or Impact To Patient 3147 3147
Insufficient Information 1582 1582
No Known Impact Or Consequence To Patient 940 940
Foreign Body In Patient 456 456
No Patient Involvement 426 426
No Information 217 217
Unspecified Tissue Injury 188 188
No Code Available 173 173
Hemorrhage/Bleeding 167 167
Device Embedded In Tissue or Plaque 69 69
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 51 51
Injury 49 49
Pain 49 49
Tissue Damage 47 47
Failure to Anastomose 47 47
Laceration(s) 46 46
Unspecified Infection 45 45
Tissue Breakdown 45 45
Burn(s) 42 42
Hernia 39 39
Peritoneal Laceration(s) 38 38
Unintended Radiation Exposure 37 37
Blood Loss 33 33
Bowel Perforation 31 31
Hematoma 29 29
Seroma 27 27
Obstruction/Occlusion 27 27
Superficial (First Degree) Burn 27 27
Patient Problem/Medical Problem 25 25
Post Operative Wound Infection 23 23
Abscess 22 22
Perforation 21 21
Death 20 20
Abdominal Pain 19 19
Burn, Thermal 18 18
Electric Shock 17 17
Urinary Retention 17 17
Radiation Exposure, Unintended 16 16
Fistula 14 14
Peritonitis 13 13
Adhesion(s) 13 13
Liver Laceration(s) 13 13
Sepsis 12 12
Fever 11 11
Urinary Tract Infection 11 11
Hematuria 8 8
Wound Dehiscence 8 8
Great Vessel Perforation 8 8
Necrosis 8 8

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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