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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
Product CodeLWH
Regulation Number 880.2740
Device Class 1

MDR Year MDR Reports MDR Events
2016 40 40
2017 107 107
2018 64 64
2019 66 66
2020 33 33
2021 35 35
2022 41 41
2023 39 39
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 272 272
False Negative Result 114 114
Device Displays Incorrect Message 14 14
Adverse Event Without Identified Device or Use Problem 8 8
Material Fragmentation 5 5
Particulates 5 5
Material Frayed 4 4
No Display/Image 3 3
Detachment of Device or Device Component 3 3
Device Operates Differently Than Expected 3 3
Defective Device 3 3
Material Integrity Problem 3 3
Material Deformation 2 2
Electromagnetic Compatibility Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Output Problem 2 2
Insufficient Information 2 2
Data Problem 2 2
Device Sensing Problem 2 2
Charging Problem 2 2
False Reading From Device Non-Compliance 2 2
Component Missing 2 2
Material Separation 2 2
Computer Software Problem 2 2
Break 2 2
Loose or Intermittent Connection 2 2
Failure to Power Up 2 2
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Incorrect Interpretation of Signal 1 1
Unsealed Device Packaging 1 1
Calibration Error 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Defective Alarm 1 1
Unraveled Material 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Radiofrequency Interference (RFI) 1 1
Flaked 1 1
Contamination /Decontamination Problem 1 1
Communication or Transmission Problem 1 1
Connection Problem 1 1
Electrical Shorting 1 1
Device Fell 1 1
Intermittent Energy Output 1 1
Appropriate Term/Code Not Available 1 1
Packaging Problem 1 1
Physical Property Issue 1 1
Protective Measures Problem 1 1
No Apparent Adverse Event 1 1
Human-Device Interface Problem 1 1
Inappropriate or Unexpected Reset 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Blocked Connection 1 1
Calibration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 105 105
No Clinical Signs, Symptoms or Conditions 98 98
No Patient Involvement 84 84
No Information 62 62
No Known Impact Or Consequence To Patient 34 34
Radiation Exposure, Unintended 25 25
Insufficient Information 19 19
Foreign Body In Patient 13 13
Unintended Radiation Exposure 10 10
Device Embedded In Tissue or Plaque 4 4
No Code Available 3 3
Hemorrhage/Bleeding 2 2
Abnormal Vaginal Discharge 1 1
Abdominal Pain 1 1
Foreign Body Reaction 1 1
Bone Fracture(s) 1 1
Injury 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
2 Stryker Instruments Div. of Stryker Corporation II Apr-13-2016
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