(b)(4).Batch # t9422g.Investigation summary: the analysis results confirmed that the pouch device was returned fully deployed and with the suture torn.A sample bag was returned detached.Upon evaluation, the bag was noted to be torn at the bottom end (not at the seams).The torn portion was noted to be stretched.In order to evaluate the internal components, the device was disassembled.Upon disassembly of the device, no anomalies were noted with the internal components.Each device is 100% visually inspected prior to shipment and damage of this magnitude would have been detected during this inspection.However, a potential cause of the torn bag is attempting to remove the bag, with specimen, through the trocar or by forcing the bag through the access site as this may lead to bag rupture and spillage of contents.A manufacturing record evaluation was performed for the finished device batch number and no non-conformances were identified.
|