As reported, the 3dmax light mesh separated from the edge seal after the mesh was implanted laparoscopically in the abdominal cavity and was immediately removed.The subject device was returned for evaluation.Visual evaluation of the sample finds tear/separation in the edge seal.No manufacturing anomalies found.Based on the sample evaluation and investigation performed, the root cause for the issue is determined to have inadvertently occurred during user/device interface while inserting the mesh.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 688 units released for distribution in november, 2021.The size of the trocar used was not reported.Per the instructions-for-use (ifu), supplied with the device, ¿use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force".Sample evaluated.
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As reported, during a laparoscopic hernia repair procedure on (b)(6) 2022, the bard/davol 3dmax light mesh was separated from the edge seal after the mesh was implanted in the abdominal cavity and was immediately removed from the patient¿s body.It was also reported that another mesh was used to complete the procedure and there was no reported patient injury.
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