According to the reporter: occurred post-operatively, approximately 1 year and 8 months after receiving a composite parastomal mesh as part of a modified sugarbaker repair for a rectal extirpation for cancer.The original repair included composite parastomal mesh fixed with permanent tackers and sutures.The patient did not present with any immediate problems following the procedure.He returned to the hospital due to an acutely developed small bowel obstruction.He underwent emergency laparoscopic surgery where a small bowel loop was discovered inside a fracture hole in the mesh.The bowel loop was vital and was repositioned following repair of the mesh hole with nylon suture.The mesh appeared normal besides the fracture hole.The issue caused temporary injury and tissue damage and required surgical intervention.Patient status reported as alive, no injury.Relevant medical history: rectal extirpation for cancer.
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Evaluation summary: an evaluation was performed on the device.The visual examination of the provided picture shows a well-integrated mesh in vivo with a similar knitting pattern than pcopm meshes.At least 14 tacks are surrounded a big hole in the textile (>10 pores).However due to the picture quality, it is not possible to determine where exactly is located the hole in the mesh (2d-band or 3d-band), if it is a tear or a cut, and if the mesh have been overstretched or not.Without the sample a detailed investigation could not be performed.Conclusion of the visual examination: the root cause could not be determined.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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