As reported, during a laparoscopic ventral hernia repair procedure on (b)(6) 2022 using the bard/davol ventralight st w/echo ps after fixating the mesh and removing the balloon it was noted that one of the connectors was missing.It was reported that the surgeon searched for the connector but, could not find the missing component and believes that it remains in the patient.No additional intervention has been performed.There was no reported patient injury.
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As reported the sample is not available for return.Based on the information provided and without having the sample to evaluate, no conclusions can be made.To date, this is the only reported complaint for this manufacturing lot.Addendum: this is an addendum to the initial mdr submitted to document the results of sample evaluation.Visual evaluation confirms that one purple connector is detached/missing from the balloon.Inspection of the location on the balloon where the connector would be present finds a tear in the balloon material.This allowed for the connector to detach.No manufacturing anomalies were found.Based on the sample evaluation and investigation performed, the most probable root cause is that the connector likely became caught up while removing the balloon from the patient inadvertently tearing the balloon.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint for this manufacturing lot of 116 units released for distribution in march,2022 updated fields: b4, d9, g3, g6, h2, h3, h4, h6, h10.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : sample evaluated.
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As reported, during a laparoscopic ventral hernia repair procedure on (b)(6) 2022 using the bard/davol ventralight st w/echo ps after fixating the mesh and removing the balloon it was noted that one of the connectors was missing.It was reported that the surgeon searched for the connector but, could not find the missing component and believes that it remains in the patient.No additional intervention has been performed.There was no reported patient injury.
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