TPLC - Total Product Life Cycle

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Device	mediastinoscope, surgical
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	94	94
Detachment of Device or Device Component	29	29
Crack	11	11
Component Missing	11	11
Loose or Intermittent Connection	10	10
Sharp Edges	5	5
Mechanical Problem	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Naturally Worn	4	4
Poor Quality Image	4	4
Material Integrity Problem	3	3
Material Deformation	3	3
Material Separation	3	3
Defective Component	2	2
Scratched Material	2	2
Output Problem	2	2
Material Split, Cut or Torn	1	1
Disconnection	1	1
Microbial Contamination of Device	1	1
Pitted	1	1
Optical Problem	1	1
Device Handling Problem	1	1
Missing Information	1	1
Connection Problem	1	1
Loss of or Failure to Bond	1	1
Physical Resistance/Sticking	1	1
Material Fragmentation	1	1
Degraded	1	1
Material Discolored	1	1
Optical Obstruction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	174	174
Needle Stick/Puncture	4	4
Unspecified Respiratory Problem	3	3
Insufficient Information	1	1
Low Blood Pressure/ Hypotension	1	1
Full thickness (Third Degree) Burn	1	1