Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted or explanted.It is unknown if the complainant part will be returned for manufacturer evaluation.Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4) - manufacturing date: november 26, 2013.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that the pulling trigger on the handle of a zipfix application instrument was sticking during a coronary artery bypass graft (cabg) procedure on (b)(6) 2015.The surgeon was closing the patient's sternum with synthes zip-ties.The zipfix instrument was needed to tighten the ties down.When the surgeon squeezed the application instrument, however, the handle on the gun would not release.The surgeon needed to manually pull the handle out every time it was squeezed.The procedure was ultimately completed successfully with no reported patient harm or surgical delay.This report is 1 of 1 for (b)(4).
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