This device was received at oem-wom for evaluation.Based on the oem-wom investigation report attached, the reported failure ¿robotic cases of subcutaneous emphysema and crepitus¿ was not confirmed.According to wom: visual inspection the device was received on sep 13, 2021 for evaluation.There are no indications of transport damage or misuse.Functional inspection functional inspection based on test instructions v 6.0 indicated the returned device passed all criteria.Dimensional inspection due to the nature of the reported event, the dimensional inspection was deemed unnecessary and therefore not performed.Investigation conclusion the results of the investigation performed indicated that the returned pneumoclear plus co2 conditioning insufflator, catalog#620050000, sn (b)(6) is working according to specification.Probable root cause: there are no indications of a manufacturing issue.The events, all reported by the same hospital, are all well-known side effects which can occur during laparoscopic procedures and can be well controlled by the or team in terms of e.G., trocar placement, patient ventilation, positioning, and insufflator settings.The most probable root cause is that the user may not have chosen a suitable pressure for the respective patient or did not adjust the settings during a potentially prolonged procedure accordingly, as well as may not have ideally positioned the patient or patient ventilation may have been insufficient.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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