Catalog Number 387.347 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided for reporting.Date of event/therapy date was reported as (b)(6) 2017.It is unknown if all the devices malfunctioned on the same day or during same procedure.Device is an instrument and is not implanted / explanted.(b)(6).Device history records review was completed for part# 387.347, lot# 1352819.Manufacturing location: (b)(4), manufacturing date: jun 22, 2005.No non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.Device was 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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Event Description
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Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the reported clamps were stiff and coming off the ring very easily.The vascular surgeons felt that this is potentially dangerous around vessels.Reportedly, this occurred during use on the patient.However, it is unknown if this occurred during multiple occasions or the exact date it occurred.Patient and surgery outcome were not reported.Synfram ½ holding (part# 387.337, quantity 3).Synfram holding (part# 387.336, quantity 3).This report is for one (1) synframe ring clamp.This is report 2 of 8 for (b)(4).
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Manufacturer Narrative
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Product development investigation was completed.A visual inspection, device history records review and function test was completed as part of this investigation.Upon visual and incoming inspection of the complaint devices, it was noted that on some position the coating is already gone.Furthermore, the articles are showing marks and deformation from usage over the years.During investigation, a functional test was performed.The clamps passed the functional test.The reported devices were assembled according to drawing, and went through 100% functional test before they left the production.This complaint was classified as normal wear and tear, and such instruments must be replaced from time to time.Complained issue could not be replicated and/or confirmed based on the available information.Device was 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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Search Alerts/Recalls
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