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Catalog Number 5955460 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Fistula (1862); No Code Available (3191)
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Event Date 01/01/2014 |
Event Type
Injury
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Event Description
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The following was reported to davol: the patient was implanted with a ventralight st w/echo and a non bard/davol fixation device.During the case the doctor did not follow the prescribed method of removal and as a result a fragment of the davol inflation tube was left behind the mesh.Approximately, 3 weeks post op the patient required a procedure to repair an intestinal fistula.During the course of the procedure the previously placed mesh, and portion of the inflation assembly were explanted.As reported the root cause of the fistula formation is undetermined by the hospital/doctor.However, as reported they could not rule out the mesh or the non bard/davol fixation device as possibly contributing to the event.
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Manufacturer Narrative
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Based on the information available at this time, no definitive conclusions can be made.Fistula formation is listed in the ifu as a known possible complication.A review of the manufacturing records showed that this lot was manufactured with no anomalies.The malfunction related to the portion of the inflation device being left in the body was reported to fda as 1213643-2014-00403.As reported, there is no relationship between the portion of the inflation device being left in the body and the patients fistula formation.This mdr includes all patient, event and device information davol has received to date.If additional information is obtained, a follow up mdr will be submitted.
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Search Alerts/Recalls
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