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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 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 4
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
CLEARCAM, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
DANNIK
  SUBSTANTIALLY EQUIVALENT 1
DANNIK, LLC
  SUBSTANTIALLY EQUIVALENT 1
EIZO CORPORATION
  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 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
LAGIS ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LAZURITE HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 2
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
MEDICONCEPTS TECHNOLOGY (SHENZHEN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS, INC.
  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
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 2
SIDAM S.R.L
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONY ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 12
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 6
SURGICAL INNOVATIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
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
2020 2620 2620
2021 3430 3430
2022 3945 3945
2023 6005 6005
2024 6047 6047
2025 767 767

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 4068 4068
Break 2876 2876
Detachment of Device or Device Component 2787 2787
Poor Quality Image 1570 1570
Material Split, Cut or Torn 1461 1461
Peeled/Delaminated 1229 1229
Inflation Problem 1203 1203
Communication or Transmission Problem 1186 1186
Leak/Splash 910 910
Material Fragmentation 738 738
Crack 548 548
Adverse Event Without Identified Device or Use Problem 526 526
Image Orientation Incorrect 452 452
Display or Visual Feedback Problem 423 423
Packaging Problem 349 349
Mechanical Problem 346 346
Erratic or Intermittent Display 291 291
Decrease in Pressure 275 275
Fluid/Blood Leak 267 267
Output Problem 265 265
Material Integrity Problem 260 260
Insufficient Information 250 250
Loss of or Failure to Bond 235 235
Gas/Air Leak 230 230
Failure to Fire 209 209
Optical Problem 206 206
Image Display Error/Artifact 191 191
Difficult to Insert 169 169
Noise, Audible 156 156
Material Separation 154 154
Unintended System Motion 146 146
Corroded 142 142
Positioning Failure 138 138
Material Rupture 135 135
Device Contaminated During Manufacture or Shipping 127 127
Failure to Power Up 125 125
Premature Separation 119 119
Electrical /Electronic Property Problem 117 117
Overheating of Device 116 116
Fracture 104 104
Connection Problem 101 101
Product Quality Problem 100 100
Mechanics Altered 98 98
Difficult to Remove 92 92
Fogging 91 91
Device Slipped 89 89
Delivered as Unsterile Product 82 82
Material Deformation 80 80
Degraded 80 80
Mechanical Jam 80 80

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18594 18594
No Consequences Or Impact To Patient 1645 1645
Insufficient Information 1492 1492
Foreign Body In Patient 390 390
No Known Impact Or Consequence To Patient 345 345
No Patient Involvement 280 280
Unspecified Tissue Injury 180 180
Hemorrhage/Bleeding 150 150
No Information 91 91
No Code Available 74 74
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 46 46
Laceration(s) 43 43
Tissue Breakdown 42 42
Failure to Anastomose 40 40
Burn(s) 40 40
Peritoneal Laceration(s) 38 38
Device Embedded In Tissue or Plaque 37 37
Pain 36 36
Unspecified Infection 34 34
Unintended Radiation Exposure 32 32
Bowel Perforation 29 29
Hernia 27 27
Injury 26 26
Superficial (First Degree) Burn 26 26
Seroma 23 23
Abscess 21 21
Blood Loss 21 21
Post Operative Wound Infection 20 20
Perforation 20 20
Obstruction/Occlusion 18 18
Hematoma 18 18
Abdominal Pain 17 17
Electric Shock 15 15
Tissue Damage 15 15
Fistula 14 14
Death 13 13
Liver Laceration(s) 12 12
Sepsis 12 12
Patient Problem/Medical Problem 11 11
Urinary Retention 10 10
Peritonitis 10 10
Urinary Tract Infection 9 9
Adhesion(s) 8 8
Wound Dehiscence 8 8
Necrosis 8 8
Dysphagia/ Odynophagia 7 7
Great Vessel Perforation 7 7
Pulmonary Emphysema 6 6
Hematuria 6 6
Radiation Exposure, Unintended 6 6

Recalls
Manufacturer Recall Class Date Posted
1 ASPEN SURGICAL II Jun-27-2024
2 Aesculap Inc II Mar-01-2024
3 Baxter Healthcare Corporation II Jul-26-2021
4 Canadian Hospital Specialties Ltd. II Jul-17-2024
5 Carefusion 2200 Inc II Sep-30-2024
6 CooperSurgical, Inc. II Feb-05-2024
7 Covidien LP II Apr-26-2023
8 Covidien, LP II Apr-03-2024
9 Covidien, LP II Apr-12-2023
10 Davol, Inc. II Jul-22-2022
11 Davol, Inc. II Jun-30-2022
12 Genicon, Inc. II May-14-2020
13 Olympus Corporation of the Americas II Apr-22-2020
14 Sharp Medical Products II Apr-06-2021
15 Stryker Corporation II Mar-07-2022
16 Stryker Corporation II Apr-15-2021
17 Surgical Innovations Ltd II Jul-18-2022
18 Surgical Innovations Ltd II May-17-2023
19 Surgical Innovations Ltd II Sep-29-2022
20 UNIMAX MEDICAL SYSTEMS INC II Sep-17-2024
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