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 laryngoscope, non-rigid
Product CodeCAL
Regulation Number 868.5530
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 2 2
2021 60 60
2022 258 258
2023 268 268
2024 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Break 311 311
Fluid/Blood Leak 204 204
Loose or Intermittent Connection 74 74
Obstruction of Flow 11 11
Optical Distortion 6 6
Material Fragmentation 6 6
No Display/Image 5 5
Optical Problem 5 5
Overcorrection 3 3
Poor Quality Image 3 3
Material Separation 3 3
Microbial Contamination of Device 2 2
Nonstandard Device 2 2
Device Reprocessing Problem 2 2
Detachment of Device or Device Component 2 2
Material Integrity Problem 2 2
Defective Device 1 1
Unintended Movement 1 1
Insufficient Information 1 1
Failure to Clean Adequately 1 1
Inaccurate Information 1 1
Erratic or Intermittent Display 1 1
Flaked 1 1
Material Frayed 1 1
Leak/Splash 1 1
Fracture 1 1
Unintended System Motion 1 1
Mechanical Problem 1 1
Component Missing 1 1
Residue After Decontamination 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 632 632
Insufficient Information 9 9
Patient Problem/Medical Problem 4 4
Respiratory Tract Infection 2 2
Foreign Body In Patient 2 2
No Known Impact Or Consequence To Patient 1 1
Transmissible Spongiform Encephalopathy(TSE) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Karl Storz Endoscopy II Oct-29-2021
2 Karl Storz Endoscopy II Aug-27-2020
-
-