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Model Number SYM3020 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); Tissue Damage (2104); Injury (2348); No Code Available (3191)
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Event Date 08/11/2017 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturer reference number:(b)(4).Since the lot number was not provided, this information cannot be determined.(b)(4) - surgical intervention, fecal contamination, sigmoid, ileostomy, abdominal lavage, extended hospital stay.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter: the patient underwent an abdominal wall reconstruction and resection of soft tissue tumor (desmoid tumor) with mesh.The defect was 20x15cm.The wound was closed by conventional closure of planes.The fixation system was suture.The mesh used had a good appearance of color and texture.Two weeks post operatively the patient presented with enterocutaneous fistula.Upon exploration sigmoides were found under the mesh with the fistula.The event lead to extended hospital stay.There was temporary injury.There was unanticipated tissue loss.There was tissue damage.There was fecal contamination.A derivative ileostomy and segmental resection of sigmoides and retirement of mesh was done to treat the damage.The damage is not permanent.The surgical time was extended by more than 30 minutes.An abdominal lavage was performed.There will be an additional operation performed to correct the issue.
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Manufacturer Narrative
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Evaluation summary: as no lot number was provided, a review of the device history record could not be performed.All process and test criteria are verified as complying with qa specifications for all product lots prior release to market.No sample was provided for investigation.The visual examination of the provided picture shows that the picture of the mesh has been taken in vivo.The textile knitting pattern seems to match with symbotex textile knitting pattern, the green marking is also visible, however the picture does not allow to detect if a collagen film was present and its state.Neither mesh failure nor adhesions to the mesh are visible.A hole in the abdominal wall could be a fistula.Without the sample a detailed investigation could not be performed.The overlap between the mesh and the edges of the defect was insufficient and excessive tension may have been applied.The report has been added to our product complai nts database which is monitored for similar occurrences.Based on our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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