It was reported by a physician that she could not get an audio verification of the valve during the reprogramming process and that after several attempts the programmer overheated (flash and beep sound).The valve was then reprogrammed with black programmer.When the physician went to pick up the vpv, there was no ultrasound gel.The sales representative explained to the office manager that without gel, the device would not give an audio verification and after several attempts will overheat.The surgeon insisted to take the programmer for evaluation.The event led to 10 minutes delay with no patient injury.An x-ray was performed to verify the setting and the patient is in stable condition.
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Programmer was received for evaluation.Dhr - a review was performed for the vpv programmer 82-3192r, s/n: (b)(6) (lot # ctgcdn), and the lot met specifications when released on may 28th, 2015.Udi - (b)(4).The manufacturing date is may 27th, 2015.Failure analysis - the internal inspection did not confirm the reported issue as the device worked correctly.But the transmitter head had cracks.Possible root cause for this issue reported by the customer could be the lack of ultrasound gel.The root cause for the damage transmitter could be due to bump caused by a bad handling.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(6), director of regulatory programs, office of product evaluation and quality and (b)(6), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
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