TPLC - Total Product Life Cycle

• Device: oximeter, reprocessed
• Definition: same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
• Product Code: NLF
• Regulation Number: 870.2700
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
STRYKER SUSTAINABILITY SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	2
SURGICAL INSTRUMENT AND SAVINGS INC (DBA MEDLINE RENEWAL)
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	9	9
2019	11	11
2020	2	2
2021	1	1
2022	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Defective Device	5	5
Adverse Event Without Identified Device or Use Problem	3	3
Device Displays Incorrect Message	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Defective Component	2	2
Out-Of-Box Failure	2	2
Temperature Problem	2	2
Patient Device Interaction Problem	2	2
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Break	1	1
Fracture	1	1
Incorrect Measurement	1	1
No Device Output	1	1
Unable to Obtain Readings	1	1
Device Sensing Problem	1	1
Material Protrusion/Extrusion	1	1
Packaging Problem	1	1
Protective Measures Problem	1	1
Scratched Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	12	12
Inflammation	3	3
No Patient Involvement	2	2
Skin Inflammation/ Irritation	2	2
Insufficient Information	1	1
Device Embedded In Tissue or Plaque	1	1
No Code Available	1	1
Foreign Body In Patient	1	1
Ossification	1	1
Unspecified Infection	1	1
Injury	1	1
Numbness	1	1
Confusion/ Disorientation	1	1
Blood Loss	1	1