Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device microscope, surgical, general & plastic surgery
Product CodeFSO
Regulation Number 878.4700
Device Class 1

MDR Year MDR Reports MDR Events
2019 12 12
2020 7 7
2021 19 19
2022 5 5
2023 17 17
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 13 13
Unstable 7 7
Optical Problem 7 7
Device Dislodged or Dislocated 6 6
Installation-Related Problem 6 6
Use of Device Problem 6 6
Detachment of Device or Device Component 5 5
Physical Resistance/Sticking 3 3
Unexpected Shutdown 3 3
Misassembly During Maintenance/Repair 2 2
Device Handling Problem 2 2
Noise, Audible 2 2
Positioning Problem 2 2
No Apparent Adverse Event 2 2
Mechanical Problem 2 2
Component Missing 2 2
Computer Software Problem 2 2
Poor Quality Image 2 2
Energy Output Problem 1 1
Product Quality Problem 1 1
Unraveled Material 1 1
Use of Incorrect Control/Treatment Settings 1 1
Display or Visual Feedback Problem 1 1
Loose or Intermittent Connection 1 1
Failure to Calibrate 1 1
Failure to Align 1 1
Calibration Problem 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Vibration 1 1
Improper or Incorrect Procedure or Method 1 1
Misfocusing 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Operating System Becomes Nonfunctional 1 1
Insufficient Information 1 1
Reset Problem 1 1
Patient Device Interaction Problem 1 1
Break 1 1
Key or Button Unresponsive/not Working 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
Insufficient Information 6 6
No Patient Involvement 6 6
Eye Burn 5 5
No Known Impact Or Consequence To Patient 4 4
Eye Injury 3 3
Perforation of Vessels 2 2
No Consequences Or Impact To Patient 2 2
No Information 1 1
No Code Available 1 1
Laceration(s) 1 1
Tinnitus 1 1
Bruise/Contusion 1 1
Stroke/CVA 1 1
Burn, Thermal 1 1
Electric Shock 1 1
Capsular Bag Tear 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Aug-11-2022
2 Aesculap Implant Systems LLC II Jul-19-2022
3 Carl Zeiss Suzhou Co., Ltd. II Oct-26-2023
4 Leica Microsystems, Inc. II Sep-29-2022
5 Leica Microsystems, Inc. II Dec-22-2021
-
-