TPLC - Total Product Life Cycle

• Device: counter, sponge, surgical
• Regulation Description: Surgical sponge scale.
• Product Code: LWH
• Regulation Number: 880.2740
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	33	33
2021	35	35
2022	41	41
2023	39	39
2024	37	37
2025	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	135	135
False Negative Result	49	49
Device Displays Incorrect Message	8	8
Insufficient Information	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Defective Device	2	2
Material Fragmentation	2	2
Device Sensing Problem	2	2
No Apparent Adverse Event	2	2
Output Problem	1	1
Device Fell	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
High Readings	1	1
Electromagnetic Compatibility Problem	1	1
Material Deformation	1	1
Material Separation	1	1
Detachment of Device or Device Component	1	1
Electrical Shorting	1	1
Protective Measures Problem	1	1
Incorrect Interpretation of Signal	1	1
Inappropriate or Unexpected Reset	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	123	123
Insufficient Information	21	21
Unintended Radiation Exposure	19	19
No Consequences Or Impact To Patient	10	10
No Patient Involvement	8	8
No Information	7	7
Foreign Body In Patient	7	7
Radiation Exposure, Unintended	5	5
Hemorrhage/Bleeding	2	2
No Code Available	1	1
Abnormal Vaginal Discharge	1	1
Bone Fracture(s)	1	1
Foreign Body Reaction	1	1
No Known Impact Or Consequence To Patient	1	1
Unspecified Tissue Injury	1	1
Physical Asymmetry	1	1
Device Embedded In Tissue or Plaque	1	1

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