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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse
Definition Used to aid in insertion, placement, fixation, or anchoring of surgical mesh for transvaginal pelvic organ prolapse repair
Product CodePWI
Regulation Number 884.4910
Device Class 2

MDR Year MDR Reports MDR Events
2020 5 5
2021 3 3
2022 6 6
2023 8 8
2024 74 74

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 25 25
Misfire 18 18
Use of Device Problem 16 16
Retraction Problem 13 13
Adverse Event Without Identified Device or Use Problem 4 4
Break 3 3
Activation, Positioning or Separation Problem 2 2
Defective Device 2 2
Failure to Align 2 2
Failure to Advance 2 2
Firing Problem 2 2
Device-Device Incompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Entrapment of Device 1 1
Mechanical Problem 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1
Difficult to Advance 1 1
Insufficient Information 1 1
Positioning Problem 1 1
Material Twisted/Bent 1 1
Failure to Capture 1 1
Product Quality Problem 1 1
Failure to Fire 1 1
Activation Failure 1 1
Appropriate Term/Code Not Available 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 62 62
Foreign Body In Patient 12 12
Insufficient Information 10 10
Hemorrhage/Bleeding 5 5
No Known Impact Or Consequence To Patient 3 3
Unspecified Tissue Injury 3 3
Hematoma 2 2
Dyspareunia 2 2
Urinary Tract Infection 2 2
Dysuria 1 1
Fecal Incontinence 1 1
Abnormal Vaginal Discharge 1 1
Adhesion(s) 1 1
Inflammation 1 1
Muscle Weakness 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Paresthesia 1 1
Burning Sensation 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
No Patient Involvement 1 1
Micturition Urgency 1 1
Urinary Retention 1 1
Depression 1 1
Numbness 1 1
Scar Tissue 1 1
Prolapse 1 1
Balance Problems 1 1
Pain 1 1
No Consequences Or Impact To Patient 1 1
Bacterial Infection 1 1
Constipation 1 1
Erosion 1 1
Ambulation Difficulties 1 1
Increased Sensitivity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jul-30-2024
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