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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
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 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 4
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
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
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 4343 4343

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 3826 3826
Detachment of Device or Device Component 2993 2993
Break 2960 2960
Poor Quality Image 1446 1446
Material Split, Cut or Torn 1386 1386
Inflation Problem 1275 1275
Peeled/Delaminated 1130 1130
Communication or Transmission Problem 1057 1057
Leak/Splash 997 997
Packaging Problem 736 736
Material Fragmentation 679 679
Adverse Event Without Identified Device or Use Problem 580 580
Crack 495 495
Mechanical Problem 393 393
Display or Visual Feedback Problem 382 382
Image Orientation Incorrect 376 376
Fluid/Blood Leak 288 288
Decrease in Pressure 278 278
Loss of or Failure to Bond 271 271
Insufficient Information 251 251
Erratic or Intermittent Display 251 251
Output Problem 243 243
Failure to Fire 241 241
Material Integrity Problem 236 236
Difficult to Insert 229 229
Difficult to Remove 218 218
Gas/Air Leak 208 208
Image Display Error/Artifact 192 192
Optical Problem 188 188
Material Rupture 177 177
Material Separation 176 176
Noise, Audible 165 165
Positioning Failure 146 146
Unintended System Motion 139 139
Corroded 137 137
Device Contaminated During Manufacture or Shipping 127 127
Overheating of Device 127 127
Electrical /Electronic Property Problem 117 117
Premature Separation 108 108
Failure to Power Up 108 108
Fracture 107 107
Mechanics Altered 105 105
Product Quality Problem 102 102
Mechanical Jam 101 101
Component Missing 98 98
Device Slipped 87 87
Defective Device 87 87
Delivered as Unsterile Product 85 85
Material Deformation 82 82
Manufacturing, Packaging or Shipping Problem 81 81

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16377 16377
No Consequences Or Impact To Patient 3147 3147
Insufficient Information 1333 1333
No Known Impact Or Consequence To Patient 940 940
No Patient Involvement 426 426
Foreign Body In Patient 375 375
No Information 217 217
No Code Available 173 173
Unspecified Tissue Injury 168 168
Hemorrhage/Bleeding 141 141
Device Embedded In Tissue or Plaque 68 68
Injury 49 49
Tissue Damage 47 47
Failure to Anastomose 45 45
Unspecified Infection 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 41 41
Burn(s) 41 41
Pain 38 38
Peritoneal Laceration(s) 38 38
Hernia 37 37
Laceration(s) 36 36
Tissue Breakdown 35 35
Blood Loss 33 33
Bowel Perforation 28 28
Superficial (First Degree) Burn 27 27
Hematoma 27 27
Seroma 26 26
Patient Problem/Medical Problem 25 25
Unintended Radiation Exposure 24 24
Post Operative Wound Infection 23 23
Obstruction/Occlusion 22 22
Death 20 20
Abscess 20 20
Burn, Thermal 18 18
Abdominal Pain 18 18
Electric Shock 17 17
Urinary Retention 16 16
Radiation Exposure, Unintended 16 16
Perforation 14 14
Fistula 14 14
Peritonitis 13 13
Sepsis 11 11
Liver Laceration(s) 11 11
Fever 11 11
Wound Dehiscence 8 8
Adhesion(s) 8 8
Dysphagia/ Odynophagia 8 8
Necrosis 6 6
Low Blood Pressure/ Hypotension 6 6
Urinary Incontinence 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 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
21 UNIMAX MEDICAL SYSTEMS INC II Sep-17-2024
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