TPLC - Total Product Life Cycle

• Device: counter, sponge, surgical
• Product Code: LWH
• Regulation Number: 880.2740
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	66	66
2020	33	33
2021	35	35
2022	41	41
2023	39	39
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	150	150
False Negative Result	65	65
Adverse Event Without Identified Device or Use Problem	5	5
Material Fragmentation	4	4
Device Displays Incorrect Message	4	4
Detachment of Device or Device Component	2	2
Device Sensing Problem	2	2
Defective Device	2	2
Electromagnetic Compatibility Problem	2	2
Insufficient Information	2	2
Material Deformation	2	2
Device Fell	1	1
Inappropriate or Unexpected Reset	1	1
Output Problem	1	1
Protective Measures Problem	1	1
No Apparent Adverse Event	1	1
Electrical Shorting	1	1
Loose or Intermittent Connection	1	1
Unsealed Device Packaging	1	1
Incorrect Interpretation of Signal	1	1
Material Separation	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	97	97
No Information	43	43
No Consequences Or Impact To Patient	25	25
Insufficient Information	19	19
No Patient Involvement	16	16
Radiation Exposure, Unintended	11	11
Unintended Radiation Exposure	10	10
Foreign Body In Patient	6	6
Hemorrhage/Bleeding	2	2
Abnormal Vaginal Discharge	1	1
Foreign Body Reaction	1	1
Bone Fracture(s)	1	1
No Known Impact Or Consequence To Patient	1	1
Physical Asymmetry	1	1
Device Embedded In Tissue or Plaque	1	1
No Code Available	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Instruments Div. of Stryker Corporation	II	Jul-22-2022