Catalog Number 03.221.006 |
Device Problem
Component Missing (2306)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device used for treatment, not diagnosis.No patient involvement reported.Implant and explant dates: device is an instrument and is not implanted/explanted.Date returned to manufacturer.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part #: 03.221.006; lot #: 2034.Dhr was not available as device is older than 15 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to (filing and archiving of specification documents) version ai, which was in place till (b)(6)2014.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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It was reported that a cable cutter part was found broken in sterile processing.The device cannot function due to a missing screw.The cable cutter was determined to be broken after it was reported that a missing screw is causing the device not to function properly.No patient or surgeon was involved.This complaint is for one (1) device.Concomitant devices report: [blade for cable cutter] (part #: 03.221.008, lot #: unknown, quantity: 1).This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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Corrected data: the initial complaint was reviewed and found not reportable as the component part number 03.221.006 was inadvertently reported.Part number should have been 03.221.007 (trigger handle f/cable cutter) and will be reported on the other report.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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