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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device microscope, surgical, general & plastic surgery
Regulation Description Surgical microscope and accessories.
Product CodeFSO
Regulation Number 878.4700
Device Class 1

MDR Year MDR Reports MDR Events
2021 19 19
2022 5 5
2023 17 17
2024 15 15
2025 17 17
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 13 13
Optical Problem 9 9
Detachment of Device or Device Component 6 6
Use of Device Problem 6 6
Insufficient Information 5 5
Unexpected Shutdown 4 4
Unstable 3 3
Computer Software Problem 3 3
Break 3 3
Mechanical Problem 3 3
Use of Incorrect Control/Treatment Settings 3 3
Noise, Audible 2 2
No Apparent Adverse Event 2 2
Component Missing 2 2
Positioning Problem 2 2
Smoking 2 2
Unintended Electrical Shock 2 2
Poor Quality Image 2 2
Physical Resistance/Sticking 2 2
Material Integrity Problem 1 1
Energy Output Problem 1 1
Contamination /Decontamination Problem 1 1
Key or Button Unresponsive/not Working 1 1
Unraveled Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Misassembly During Maintenance/Repair 1 1
Calibration Problem 1 1
Computer Operating System Problem 1 1
Communication or Transmission Problem 1 1
Device Handling Problem 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1
Material Split, Cut or Torn 1 1
Reset Problem 1 1
Operating System Becomes Nonfunctional 1 1
Failure to Calibrate 1 1
Image Orientation Incorrect 1 1
Suction Problem 1 1
Connection Problem 1 1
Display or Visual Feedback Problem 1 1
Loose or Intermittent Connection 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1
Temperature Problem 1 1
Circuit Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 39 39
Eye Burn 8 8
Insufficient Information 7 7
Capsular Bag Tear 4 4
Eye Injury 3 3
Electric Shock 2 2
Abrasion 2 2
Perforation of Vessels 2 2
Swelling/ Edema 2 2
Bruise/Contusion 2 2
Superficial (First Degree) Burn 1 1
Head Injury 1 1
Burn(s) 1 1
Laceration(s) 1 1
Visual Impairment 1 1
Corneal Edema 1 1
Tinnitus 1 1
Hemorrhage/Bleeding 1 1
Full thickness (Third Degree) Burn 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 Aesculap Inc II Jun-12-2024
4 Carl Zeiss Suzhou Co., Ltd. II Oct-26-2023
5 Leica Microsystems, Inc. II Sep-29-2022
6 Leica Microsystems, Inc. II Dec-22-2021
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