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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
AB MEDICA SAS
  SUBSTANTIALLY EQUIVALENT 1
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 RESOURCES CORP.
  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 6
ASCLEPION LASER TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 2
BARCO N.V.
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER LABORATORIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU ANKANG MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
DANNIK, LLC
  SUBSTANTIALLY EQUIVALENT 1
EIZO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FREYJA HEALTHCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
HANGZHOU HAWK OPTICAL ELECTRONIC INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU VICTION MEDICAL TECHNOLOGY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 2
HUMAN XTENSIONS , LTD.
  SUBSTANTIALLY EQUIVALENT 5
HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INCORE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRATED ENDOSCOPY, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL OPERATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
JIANGSU CHANNEL MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ SE & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
KMS MEDICAL TECHNOLOGY CO., LTD.
  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
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 1
OUI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PARALLEL ROBOTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
PLASMATICA, LTD.
  SUBSTANTIALLY EQUIVALENT 1
REGER MEDIZINTECHNIK, GMBH
  SUBSTANTIALLY EQUIVALENT 1
REVOLVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SANTA BARBARA IMAGING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SCHOELLY FIBEROPTIC GMBH
  SUBSTANTIALLY EQUIVALENT 2
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SCOPIX , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEJONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN SOPHWAY TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SINOLINKS MEDICAL INNOVATION, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 9
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 9
SURGICAL INNOVATIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL PRINCIPALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU SHENYUN MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
  SUBSTANTIALLY EQUIVALENT 2
TAIWAN SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
THERMASOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TROCARE, LLC
  SUBSTANTIALLY EQUIVALENT 2
UNIMAX MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
US MEDICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VEOL MEDICAL TECHNOLOGIES PVT , LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIGOR MEDICAL TECHNOLOGIES , LTD.
  SUBSTANTIALLY EQUIVALENT 1
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING 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
ZHEJIANG HEALNOC TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI DIPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 3431 3437
2022 3945 3971
2023 6002 6007
2024 6048 6052
2025 5936 5936
2026 3100 3101

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 4412 4414
Break 3519 3526
Detachment of Device or Device Component 3460 3465
Poor Quality Image 2427 2429
Material Split, Cut or Torn 1833 1833
Communication or Transmission Problem 1542 1542
Peeled/Delaminated 1469 1469
Inflation Problem 1297 1297
Leak/Splash 1062 1064
Material Fragmentation 934 934
Erratic or Intermittent Display 791 791
Loss of or Failure to Bond 735 735
Image Orientation Incorrect 708 708
Crack 685 685
Display or Visual Feedback Problem 623 623
Adverse Event Without Identified Device or Use Problem 506 507
Mechanical Problem 358 358
Output Problem 347 347
Material Integrity Problem 343 344
Gas/Air Leak 333 333
Decrease in Pressure 325 325
Fluid/Blood Leak 280 280
Insufficient Information 275 275
Optical Problem 264 264
Failure to Fire 234 234
Overheating of Device 226 226
Image Display Error/Artifact 215 216
Difficult to Insert 201 201
Material Separation 190 190
Material Deformation 184 184
Noise, Audible 183 183
Connection Problem 179 181
Failure to Power Up 172 172
Unintended System Motion 167 167
Packaging Problem 166 166
Corroded 165 165
Scratched Material 162 162
Positioning Failure 156 156
Device Contaminated During Manufacture or Shipping 155 156
Delivered as Unsterile Product 141 141
Premature Separation 141 141
Smoking 141 142
Temperature Problem 140 140
Fracture 137 137
Electrical /Electronic Property Problem 125 125
Degraded 122 122
Product Quality Problem 109 109
Fogging 102 102
Loose or Intermittent Connection 101 101
Device Slipped 97 97

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25840 25873
Insufficient Information 1861 1867
Foreign Body In Patient 474 476
Unspecified Tissue Injury 196 196
Hemorrhage/Bleeding 186 186
No Consequences Or Impact To Patient 132 132
Laceration(s) 77 77
Tissue Breakdown 62 62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 61 61
Unintended Radiation Exposure 52 52
Burn(s) 52 52
Pain 44 44
Peritoneal Laceration(s) 42 42
Failure to Anastomose 33 33
Unspecified Infection 32 32
Hernia 30 30
Superficial (First Degree) Burn 28 28
Bowel Perforation 28 28
Obstruction/Occlusion 25 25
Device Embedded In Tissue or Plaque 24 24
Abdominal Pain 21 21
Seroma 20 20
Perforation 20 20
Fistula 16 16
Electric Shock 15 15
Post Operative Wound Infection 14 14
Urinary Retention 14 14
Abscess 14 14
Liver Laceration(s) 14 15
Adhesion(s) 13 13
Hematoma 13 13
Urinary Tract Infection 13 13
Sepsis 12 12
Bowel Burn 12 12
Urinary Incontinence 11 11
No Patient Involvement 11 11
Great Vessel Perforation 10 10
Hematuria 9 9
Urethral Stenosis/Stricture 9 9
Dysphagia/ Odynophagia 8 8
Unspecified Gastrointestinal Problem 8 8
Perforation of Vessels 8 8
Stenosis 7 7
Wound Dehiscence 7 7
Fever 7 7
Necrosis 6 6
Pulmonary Emphysema 6 6
Abrasion 6 6
Unspecified Hepatic or Biliary Problem 5 5
Inflammation 5 5

Recalls
Manufacturer Recall Class Date Posted
1 ASPEN SURGICAL II Jun-27-2024
2 Aesculap Inc II Oct-24-2025
3 Aesculap Inc II Mar-01-2024
4 Applied Medical Resources Corp II Jan-02-2026
5 Baxter Healthcare Corporation II Jul-26-2021
6 Canadian Hospital Specialties Ltd. II Jul-17-2024
7 Carefusion 2200 Inc II Sep-30-2024
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 Sharp Medical Products II Apr-06-2021
15 Stryker Corporation II Jul-23-2025
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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