Investigation summary: an internal complaint (call (b)(4)) was received indicating a coated electrode (part 88-000m13c, lot 45861031) functioned intermittently and that the protective plastic on the end split during use.A sample was received (b)(4) 2018, and confirmed the reported issue.Photos of the defective sample were sent to the manufacturer may 4, 2018.The work order was reviewed for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The electrode is manufactured by modern medical equipment.Similar complaints for this item were identified in a three-year review of supplier corrective action report (scar) and supplier notification letter logs.Therefore, a scar was issued to modern medical.As of the date of this report, a response has not been received from the manufacturer.A response is due (b)(6) 2018.The investigation is ongoing at this time.When new and critical information becomes available, this report will be updated.
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Root cause: the root cause could not be determined.The device manufacturer, modern medical, performed testing on the returned sample as well as three retained samples from the same lot.The manufacturer was unable to repeat the reported failure during simulated use testing on the retained samples.Simulated use testing was performed on the returned sample as well to see if the protective plastic could be split more.The existing split on the defective device did not increase after this simulated use testing.Additionally, modern medical examined its complaint records and found that no similar events have been reported from 2012 to present.Based on the investigation findings, the manufacturer has determined this is an isolated incident.Deroyal engineering performed additional simulated use testing on samples from a different lot number.Under normal use conditions, the failure was not able to be repeated.Corrective action: a supplier corrective action request (scar) was issued to the device manufacturer, modern medical.In its response, modern medical stated it would continue to monitor post-market feedback and will recognize in the future if a trend develops.Investigation summary: an internal complaint (call 43860) was received indicating a coated electrode (part 88-000m13c, lot 45861031) functioned intermittently and that the protective plastic on the end split during use.A sample was received april 30, 2018, and confirmed the reported issue.Photos of the defective sample were sent to the manufacturer may 4, 2018.The work order was reviewed for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The electrode is manufactured by modern medical equipment.Similar complaints for this item were identified in a three-year review of supplier corrective action report (scar) and supplier notification letter logs.Therefore, a scar was issued to modern medical.A response has been received.Deroyal has sold 1,199 cases of the finished good from 2016 to 2018.Each case contains 25 each, which equates to 29,975 eaches sold.A review of complaints for the same time period showed there were no similar incidents reported to deroyal.This would yield a complaint to sales ratio of 0.003336113%.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.
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