TPLC - Total Product Life Cycle

• Device: laryngoscope, non-rigid
• Regulation Description: Flexible laryngoscope.
• Product Code: CAL
• Regulation Number: 868.5530
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2021	60	62
2022	258	258
2023	268	268
2024	204	204
2025	87	87

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	424	424
Fluid/Blood Leak	262	262
Loose or Intermittent Connection	106	106
Obstruction of Flow	21	21
Poor Quality Image	6	6
Optical Distortion	6	6
Material Fragmentation	6	6
Optical Problem	5	5
No Display/Image	4	4
Detachment of Device or Device Component	4	4
Material Split, Cut or Torn	3	3
Overcorrection	3	3
Unintended Movement	3	3
Material Separation	3	3
Material Integrity Problem	2	2
Positioning Problem	2	2
Microbial Contamination of Device	2	2
Device Reprocessing Problem	2	2
Nonstandard Device	2	4
Optical Obstruction	2	2
Material Frayed	1	1
Leak/Splash	1	1
Mechanical Problem	1	1
Insufficient Information	1	1
Defective Component	1	1
Defective Device	1	1
Failure to Clean Adequately	1	1
Contamination	1	1
Component Missing	1	1
Residue After Decontamination	1	1
Erratic or Intermittent Display	1	1
Fracture	1	1
Unintended System Motion	1	1
Inaccurate Information	1	1
Failure to Disconnect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	862	864
Insufficient Information	11	11
Patient Problem/Medical Problem	2	2
Foreign Body In Patient	2	2
Respiratory Tract Infection	2	2
Transmissible Spongiform Encephalopathy(TSE)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Karl Storz Endoscopy	II	Oct-29-2021