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 Code	PWI
Regulation Number	884.4910
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	55	55
Misfire	40	41
Use of Device Problem	32	32
Retraction Problem	25	25
Adverse Event Without Identified Device or Use Problem	10	10
Defective Device	6	6
Break	4	4
Mechanical Problem	4	4
Device-Device Incompatibility	3	3
Contamination	3	3
Failure to Fire	3	3
Insufficient Information	2	2
Unsealed Device Packaging	2	2
Failure to Align	2	2
Failure to Advance	2	2
Firing Problem	2	2
Device Contaminated During Manufacture or Shipping	1	1
Physical Resistance/Sticking	1	1
Activation Problem	1	1
Difficult to Advance	1	1
Positioning Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Shipping Damage or Problem	1	1
Material Twisted/Bent	1	1
Difficult or Delayed Positioning	1	1
Failure to Capture	1	1
Product Quality Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Activation Failure	1	1
Appropriate Term/Code Not Available	1	1
Nonstandard Device	1	1
Failure to Disconnect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	134	135
Foreign Body In Patient	25	25
Insufficient Information	15	15
Hemorrhage/Bleeding	9	9
Hematoma	7	7
Pain	6	6
Urinary Incontinence	4	4
Urinary Retention	4	4
Dyspareunia	4	4
Prolapse	4	4
Unspecified Tissue Injury	4	4
Urinary Tract Infection	4	4
Unspecified Infection	3	3
Dysuria	2	2
Fecal Incontinence	2	2
Unspecified Mental, Emotional or Behavioural Problem	2	2
Micturition Urgency	2	2
Constipation	2	2
Erosion	2	2
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
Incontinence	1	1
Burning Sensation	1	1
Rash	1	1
Depression	1	1
Numbness	1	1
Chest Pain	1	1
Scar Tissue	1	1
Balance Problems	1	1
Dyspnea	1	1
Unspecified Kidney or Urinary Problem	1	1
Anxiety	1	1
Stenosis	1	1
Bacterial Infection	1	1
Ambulation Difficulties	1	1
Increased Sensitivity	1	1

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