Model Number FS19 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Constipation (3274)
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Event Date 10/26/2016 |
Event Type
Injury
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Event Description
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Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced obstructed defecation and related symptoms (pain, impaction, constipation) leading to fenix device explant.The fenix device was used as part of the surgical procedure.Uneventful surgical procedure and device implant on (b)(4) 2014.Device explant on (b)(4) 2016 due to obstructed defecation.It was noted that the device was densely embedded in fibrotic tissue around the anal canal and required both anterior and posterior incisions for device explant.-he device was found in the correct position/geometry at the time of explant.
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Manufacturer Narrative
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-addition to patient status after removal (wound healing well and patient experiencing pre-implant fi symptoms) -addition to an additional test performed after removal (flexible sigmoidoscopy) -addition to completed device evaluation.
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Event Description
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Following a surgical procedure for reinforcement of the anal sphincter due to fecal incontinence, a patient experienced obstructed defecation and related symptoms (pain, impaction, constipation) leading to fenix device explant.The fenix device was used as part of the surgical procedure.-uneventful surgical procedure and device implant on (b)(6) 2014.-device explant on (b)(6) 2016 due to obstructed defecation.It was noted that the device was densely embedded in fibrotic tissue around the anal canal and required both anterior and posterior incisions for device explant.-the device was found in the correct position/geometry at the time of explant.-patient was reported as having return of fi and rectal bleeding on (b)(6) 2016 and healing well on (b)(6) 2016.
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Search Alerts/Recalls
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