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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device counter, sponge, surgical
Regulation Description Surgical sponge scale.
Product CodeLWH
Regulation Number 880.2740
Device Class 1

MDR Year MDR Reports MDR Events
2021 35 37
2022 41 41
2023 39 40
2024 37 37
2025 35 40
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 123 123
False Negative Result 49 49
Device Displays Incorrect Message 9 9
Insufficient Information 4 4
High Readings 4 6
Adverse Event Without Identified Device or Use Problem 4 4
Low Readings 3 6
Output Problem 2 2
Defective Device 2 4
No Apparent Adverse Event 2 2
Image Display Error/Artifact 1 1
Device Fell 1 1
Unsealed Device Packaging 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Unable to Obtain Readings 1 1
Use of Device Problem 1 1
Electromagnetic Compatibility Problem 1 1
Material Deformation 1 1
Material Separation 1 1
Detachment of Device or Device Component 1 2
Device Sensing Problem 1 1
Electrical Shorting 1 1
Computer Software Problem 1 1
Protective Measures Problem 1 1
Incorrect Interpretation of Signal 1 1
Connection Problem 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 139 145
Insufficient Information 27 27
Unintended Radiation Exposure 23 23
Foreign Body In Patient 11 13
Hemorrhage/Bleeding 2 2
Abnormal Vaginal Discharge 1 1
Bone Fracture(s) 1 1
Foreign Body Reaction 1 1
Unspecified Tissue Injury 1 1
Physical Asymmetry 1 1

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