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Catalog Number 0116312 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that a brown fiber was found on the 3dmax mid mesh.At this time, no conclusion can be made.While the sample evaluation is anticipated, it has not get begun.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 165 units released for distribution in september 2020.When sample evaluation is completed, a supplemental emdr will be submitted.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.
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Event Description
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As reported, during a robotic inguinal case on (b)(6) 2020, it was identified that a brown fiber was found on the 3dmax mid xl.The issue was noticed when the sterile packaging was opened prior to handing off to the or nurse in the sterile field.As reported, the mesh was not used, another mesh was brought into the case and the procedure was successfully completed.There was no reported patient injury.
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Event Description
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As reported, during a robotic inguinal case on (b)(6) 2020, it was identified that a brown fiber was found on the 3dmax mid xl.The issue was noticed when the sterile packaging was opened prior to handing off to the or nurse in the sterile field.As reported, the mesh was not used, another mesh was brought into the case and the procedure was successfully completed.There was no reported patient injury.
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Manufacturer Narrative
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It was reported that a brown fiber was found on the 3dmax mid mesh.At this time, no conclusion can be made.While the sample evaluation is anticipated, it has not get begun.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 165 units released for distribution in september 2020.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the results of the device evaluation.The subject device was returned for evaluation.Visual inspection identified a brown fiber/ particle enclosed within the clam shell tray.Based on the investigation activities performed, the reported event is confirmed for foreign matter inside the sealed package.As the foreign matter was present in the package prior to sealing, this presented at the time of manufacturing and is confirmed for a manufacturing related condition.Sample evaluated.
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Search Alerts/Recalls
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