TPLC - Total Product Life Cycle

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Device	mediastinoscope, surgical
Regulation Description	Mediastinoscope and accessories.
Definition	If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product Code	EWY
Regulation Number	874.4720
Device Class	2

Premarket Reviews
Manufacturer	Decision
KARL STORZ ENDOSCOPY AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	2
KARL STORZ SE & CO. KG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	170	170
Detachment of Device or Device Component	73	73
Crack	18	18
Component Missing	15	15
Loose or Intermittent Connection	15	15
Poor Quality Image	9	9
Material Integrity Problem	7	7
Material Separation	7	7
Mechanical Problem	6	6
Sharp Edges	6	6
Adverse Event Without Identified Device or Use Problem	4	4
Naturally Worn	4	4
Scratched Material	3	3
Degraded	3	3
Material Fragmentation	3	3
Material Deformation	3	3
Optical Problem	3	3
Material Split, Cut or Torn	2	2
Output Problem	2	2
Defective Component	2	2
Disconnection	1	1
Physical Resistance/Sticking	1	1
Unintended Movement	1	1
Failure to Clean Adequately	1	1
Damaged Thread	1	1
Microbial Contamination of Device	1	1
Contamination /Decontamination Problem	1	1
Material Discolored	1	1
Pitted	1	1
Device Handling Problem	1	1
Missing Information	1	1
Connection Problem	1	1
Optical Obstruction	1	1
Electrical /Electronic Property Problem	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	331	331
Needle Stick/Puncture	4	4
Insufficient Information	3	3
Unspecified Respiratory Problem	3	3
Low Blood Pressure/ Hypotension	1	1
Full thickness (Third Degree) Burn	1	1