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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 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
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
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 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
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
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 5937 5937
2026 1928 1928

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 4294 4296
Break 3393 3399
Detachment of Device or Device Component 3318 3323
Poor Quality Image 2298 2300
Material Split, Cut or Torn 1771 1771
Communication or Transmission Problem 1477 1477
Peeled/Delaminated 1442 1442
Inflation Problem 1249 1249
Leak/Splash 1043 1045
Material Fragmentation 882 882
Erratic or Intermittent Display 680 680
Crack 667 667
Image Orientation Incorrect 662 662
Loss of or Failure to Bond 658 658
Display or Visual Feedback Problem 591 591
Adverse Event Without Identified Device or Use Problem 492 493
Mechanical Problem 349 349
Output Problem 328 328
Material Integrity Problem 323 324
Gas/Air Leak 316 316
Decrease in Pressure 315 315
Fluid/Blood Leak 279 279
Insufficient Information 265 265
Optical Problem 260 260
Failure to Fire 227 227
Overheating of Device 211 211
Image Display Error/Artifact 207 208
Difficult to Insert 190 190
Noise, Audible 181 181
Material Deformation 170 170
Material Separation 170 170
Connection Problem 170 172
Packaging Problem 166 166
Unintended System Motion 164 164
Failure to Power Up 164 164
Corroded 161 161
Positioning Failure 156 156
Device Contaminated During Manufacture or Shipping 154 155
Smoking 141 142
Temperature Problem 138 138
Premature Separation 136 136
Fracture 132 132
Delivered as Unsterile Product 132 132
Electrical /Electronic Property Problem 124 124
Scratched Material 119 119
Degraded 113 113
Product Quality Problem 108 108
Fogging 100 100
Loose or Intermittent Connection 99 99
Device Slipped 91 91

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24760 24793
Insufficient Information 1804 1809
Foreign Body In Patient 456 458
Unspecified Tissue Injury 193 193
Hemorrhage/Bleeding 183 183
No Consequences Or Impact To Patient 132 132
Tissue Breakdown 62 62
Laceration(s) 61 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 59 59
Burn(s) 52 52
Unintended Radiation Exposure 51 51
Peritoneal Laceration(s) 41 41
Pain 40 40
Unspecified Infection 32 32
Failure to Anastomose 31 31
Hernia 28 28
Superficial (First Degree) Burn 27 27
Bowel Perforation 27 27
Device Embedded In Tissue or Plaque 24 24
Obstruction/Occlusion 24 24
Abdominal Pain 21 21
Perforation 20 20
Seroma 17 17
Fistula 16 16
Electric Shock 15 15
Liver Laceration(s) 14 15
Abscess 14 14
Post Operative Wound Infection 13 13
Urinary Retention 12 12
Urinary Tract Infection 12 12
Hematoma 12 12
Bowel Burn 11 11
Adhesion(s) 11 11
Sepsis 11 11
No Patient Involvement 11 11
Hematuria 9 9
Great Vessel Perforation 9 9
Urinary Incontinence 9 9
Unspecified Gastrointestinal Problem 8 8
Dysphagia/ Odynophagia 8 8
Urethral Stenosis/Stricture 7 7
Perforation of Vessels 7 7
Fever 7 7
Wound Dehiscence 7 7
Necrosis 6 6
Stenosis 6 6
Pulmonary Emphysema 6 6
Abrasion 6 6
Unspecified Hepatic or Biliary Problem 5 5
Thrombosis/Thrombus 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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