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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, manual, general obstetric-gynecologic
Product CodeKOH
Regulation Number 884.4520
Device Class 1

MDR Year MDR Reports MDR Events
2014 8 8
2015 1 1
2016 34 34
2017 26 26
2018 4 4
2019 1 1
2021 3 3
2022 5 5
2023 6 6
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 76 76
Insufficient Information 3 3
Material Split, Cut or Torn 3 3
Device Operates Differently Than Expected 2 2
Device Contamination with Chemical or Other Material 1 1
Material Deformation 1 1
Mechanical Jam 1 1
Burst Container or Vessel 1 1
Entrapment of Device 1 1
Inflation Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Defective Device 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 64 64
Insufficient Information 7 7
Abnormal Vaginal Discharge 5 5
Erosion 5 5
Hemorrhage/Bleeding 5 5
Laceration(s) 4 4
Inflammation 3 3
Micturition Urgency 3 3
Abdominal Pain 3 3
Adhesion(s) 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Prolapse 3 3
Urinary Incontinence 3 3
No Known Impact Or Consequence To Patient 2 2
Abscess 2 2
Hematoma 2 2
Fistula 2 2
Unspecified Infection 2 2
Urinary Tract Infection 2 2
Pain 2 2
Scar Tissue 2 2
Constipation 2 2
No Consequences Or Impact To Patient 2 2
Stenosis 1 1
Urinary Frequency 1 1
Anxiety 1 1
Injury 1 1
Malaise 1 1
Obstruction/Occlusion 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Unspecified Heart Problem 1 1
Dyspareunia 1 1
Tachycardia 1 1
Muscle Weakness 1 1
Dizziness 1 1
Wound Dehiscence 1 1
Low Blood Pressure/ Hypotension 1 1
Incontinence 1 1
Flatus 1 1
Anemia 1 1
Diarrhea 1 1
Purulent Discharge 1 1
Fever 1 1
Swelling/ Edema 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-23-2021
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