Alleged failure: the last several boxes they ordered of 620-040-660 seem to all have the same problem.The tube set will connect to the insufflator, but within a few minutes if there is the slightest movement on the tubing, it will disconnect and the insufflator stops.They¿ve tried different lot numbers and tried it on every insufflator they own, but the same thing happens every time.Salesforce case number (b)(4).Notes from 9/12/22 no pt harm case completed successfully lot # 22f0170 rma 12122373 the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be a damaged console was used, user excessive force, extreme shipping or storage conditions.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.Please note we are discontinuing the current practice of filing malfunction medical device reports (mdrs) for reported complaints related to tubing disconnection on pneumosure tubesets.The initial event of this failure was filed on november 15th, 2017, as a serious injury, mdr 0002936485-2017-01109.This malfunction has not caused or contributed to any further deaths or serious injuries for two years.Therefore, we will discontinue filing mdrs for pneumosure tubesets due to potential loss of insufflation during surgery due to tubing disconnection.This will be the last filing related to tubing disconnection on tubesets for pneumosure.
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