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TPLC
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Device
laparoscope, gynecologic (and accessories)
Regulation Description
Gynecologic laparoscope and accessories.
Product Code
HET
Regulation Number
884.1720
Device Class
2
Premarket Reviews
Manufacturer
Decision
270SURGICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
OLYMPUS MEDICAL SYSTEMS CORP.
SUBSTANTIALLY EQUIVALENT
1
PRECISION ROBOTICS (HONG KONG) LIMITED
SUBSTANTIALLY EQUIVALENT
1
SCHOELLY FIBEROPTIC GMBH
SUBSTANTIALLY EQUIVALENT
1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SEJONG MEDICAL CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
49
49
2021
132
132
2022
216
216
2023
824
824
2024
3497
3497
2025
510
510
Device Problems
MDRs with this Device Problem
Events in those MDRs
Poor Quality Image
2177
2177
No Display/Image
554
554
Break
442
442
Communication or Transmission Problem
415
415
Optical Discoloration
272
272
Dent in Material
187
187
Failure to Cut
183
183
Material Split, Cut or Torn
176
176
Erratic or Intermittent Display
172
172
Crack
164
164
Image Display Error/Artifact
148
148
Scratched Material
130
130
Display or Visual Feedback Problem
113
113
Loose or Intermittent Connection
98
98
Fracture
97
97
Optical Problem
96
96
Leak/Splash
92
92
Output Problem
87
87
Image Orientation Incorrect
61
61
Material Integrity Problem
55
55
Material Twisted/Bent
48
48
Mechanical Problem
46
46
Material Deformation
38
38
Defective Component
38
38
Detachment of Device or Device Component
36
36
Defective Device
31
31
Dull, Blunt
30
30
Material Puncture/Hole
27
27
Electrical /Electronic Property Problem
24
24
Connection Problem
23
23
Adverse Event Without Identified Device or Use Problem
22
22
Gas/Air Leak
20
20
Difficult to Open or Close
20
20
Material Discolored
20
20
Display Difficult to Read
19
19
Unexpected Color
19
19
Contamination
17
17
Mechanical Jam
16
16
Electrical Overstress
12
12
Material Fragmentation
11
11
Fluid/Blood Leak
11
11
Failure to Clean Adequately
10
10
Corroded
10
10
Circuit Failure
9
9
Moisture or Humidity Problem
9
9
Material Opacification
8
8
Fogging
7
7
Material Separation
7
7
Sharp Edges
7
7
Unintended Movement
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5109
5109
No Consequences Or Impact To Patient
32
32
Insufficient Information
28
28
No Known Impact Or Consequence To Patient
12
12
Foreign Body In Patient
9
9
Bowel Perforation
6
6
Unspecified Tissue Injury
6
6
Burn(s)
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Injury
4
4
Hemorrhage/Bleeding
3
3
Solid Tumour
3
3
No Patient Involvement
3
3
No Code Available
2
2
Pain
2
2
Laceration(s)
2
2
Fluid Discharge
1
1
Abortion
1
1
Syncope/Fainting
1
1
Impaired Healing
1
1
Hemoptysis
1
1
Numbness
1
1
Tissue Damage
1
1
Full thickness (Third Degree) Burn
1
1
Ecchymosis
1
1
Wound Dehiscence
1
1
Not Applicable
1
1
Headache
1
1
Arrhythmia
1
1
Perforation
1
1
Respiratory Tract Infection
1
1
Blood Loss
1
1
Fever
1
1
Leiomyosarcoma
1
1
Device Embedded In Tissue or Plaque
1
1
Post Operative Wound Infection
1
1
Fibrosis
1
1
Adhesion(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aizu Olympus Co., Ltd.
II
Nov-17-2023
2
Carefusion 2200 Inc
II
Mar-30-2022
3
Karl Storz Endoscopy
II
Apr-03-2024
4
Karl Storz Endoscopy
II
Dec-18-2023
5
Olympus Corporation of the Americas
II
Jan-10-2024
6
Olympus Corporation of the Americas
II
Jan-05-2024
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