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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
Regulation Description Specialized surgical instrumentation for use with urogynecologic surgical mesh.
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
2021 3 3
2022 6 6
2023 8 8
2024 75 76
2025 90 90
2026 42 42

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 64 64
Misfire 57 58
Use of Device Problem 33 33
Retraction Problem 28 28
Adverse Event Without Identified Device or Use Problem 11 11
Mechanical Problem 5 5
Break 4 4
Defective Device 4 4
Device-Device Incompatibility 3 3
Contamination 3 3
Unsealed Device Packaging 2 2
Failure to Align 2 2
Failure to Fire 2 2
Device Contaminated During Manufacture or Shipping 1 1
Positioning Problem 1 1
Difficult or Delayed Positioning 1 1
Device Damaged Prior to Receipt by User 1 1
Tear, Rip or Hole in Device Packaging 1 1
Appropriate Device Problem Term/Code Not Available 1 1
Nonstandard Device 1 1
Difficult to Open or Close 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 162 163
Foreign Body In Patient 29 29
Insufficient Information 15 15
Hemorrhage/Blood Loss/Bleeding 12 12
Hematoma 8 8
Pain 8 8
Unspecified Tissue Injury 7 7
Prolapse 6 6
Urinary Tract Infection 5 5
Unspecified Infection 5 5
Urinary Incontinence 5 5
Dyspareunia 5 5
Constipation 4 4
Unspecified Mental, Emotional or Behavioural Problem 4 4
Urinary Retention 4 4
Abnormal Vaginal Discharge 3 3
Erosion 3 3
Inflammation 3 3
Anxiety 3 3
Micturition Urgency 3 3
Muscle Weakness/Atrophy 2 2
Dysuria 2 2
Fecal Incontinence 2 2
Urinary Frequency / Polyuria 2 2
Unspecified Kidney or Urinary Problem 2 2
Scar Tissue 2 2
Low Blood Pressure/ Hypotension 1 1
Hyperresponsive to stimuli 1 1
Bacterial Infection 1 1
Ulcer 1 1
Stenosis 1 1
Abscess 1 1
Tissue Irritation 1 1
Balance Problems 1 1
Dyspnea 1 1
Ambulation or Postural Difficulties 1 1
Numbness 1 1
Depression 1 1
Nerve Damage 1 1
Diarrhea 1 1
Chest Pain 1 1
Chills 1 1
Burning Sensation 1 1
Rash 1 1
Fever 1 1
Paresthesia 1 1
Incontinence 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Anemia 1 1
Adhesion(s) 1 1

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