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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 3
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
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 8
SURGICAL INNOVATIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL PRINCIPALS, INC.
  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
XENOCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 5938 5938
2026 560 560

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 4157 4159
Break 3233 3239
Detachment of Device or Device Component 3090 3095
Poor Quality Image 2141 2143
Material Split, Cut or Torn 1719 1719
Communication or Transmission Problem 1412 1412
Peeled/Delaminated 1380 1380
Inflation Problem 1207 1207
Leak/Splash 1023 1025
Material Fragmentation 853 853
Crack 649 649
Image Orientation Incorrect 634 634
Erratic or Intermittent Display 565 565
Display or Visual Feedback Problem 563 563
Loss of or Failure to Bond 516 516
Adverse Event Without Identified Device or Use Problem 485 486
Mechanical Problem 345 345
Output Problem 315 315
Material Integrity Problem 314 315
Decrease in Pressure 305 305
Gas/Air Leak 304 304
Fluid/Blood Leak 277 277
Insufficient Information 254 254
Optical Problem 252 252
Failure to Fire 221 221
Image Display Error/Artifact 205 206
Overheating of Device 198 198
Difficult to Insert 185 185
Noise, Audible 179 179
Packaging Problem 165 165
Unintended System Motion 161 161
Material Separation 161 161
Connection Problem 158 160
Failure to Power Up 156 156
Positioning Failure 155 155
Device Contaminated During Manufacture or Shipping 154 155
Corroded 153 153
Smoking 141 142
Premature Separation 135 135
Material Deformation 130 130
Delivered as Unsterile Product 126 126
Fracture 126 126
Electrical /Electronic Property Problem 121 121
Product Quality Problem 107 107
Temperature Problem 106 106
Degraded 105 105
Fogging 97 97
Component Missing 89 89
Device Slipped 87 87
Mechanics Altered 87 87

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23481 23514
Insufficient Information 1749 1754
Foreign Body In Patient 439 441
Unspecified Tissue Injury 193 193
Hemorrhage/Bleeding 180 180
No Consequences Or Impact To Patient 132 132
Laceration(s) 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 58 58
Tissue Breakdown 53 53
Burn(s) 51 51
Unintended Radiation Exposure 47 47
Peritoneal Laceration(s) 40 40
Pain 38 38
Unspecified Infection 32 32
Failure to Anastomose 31 31
Superficial (First Degree) Burn 27 27
Bowel Perforation 27 27
Hernia 25 25
Device Embedded In Tissue or Plaque 24 24
Obstruction/Occlusion 23 23
Abdominal Pain 21 21
Perforation 20 20
Seroma 17 17
Fistula 16 16
Liver Laceration(s) 15 16
Electric Shock 15 15
Abscess 13 13
Post Operative Wound Infection 13 13
Hematoma 12 12
Urinary Tract Infection 12 12
Adhesion(s) 11 11
No Patient Involvement 11 11
Urinary Retention 11 11
Sepsis 10 10
Great Vessel Perforation 9 9
Hematuria 9 9
Urinary Incontinence 8 8
Dysphagia/ Odynophagia 8 8
Unspecified Gastrointestinal Problem 7 7
Urethral Stenosis/Stricture 7 7
Wound Dehiscence 7 7
Bowel Burn 7 7
Perforation of Vessels 7 7
Necrosis 6 6
Fever 6 6
Pulmonary Emphysema 6 6
Stenosis 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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