Model Number H749236310020 |
Device Problem
Defective Component (2292)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4)./ device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
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Event Description
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It was reported that the brake defeat button was broken.A 1.25mm rotalink¿ plus was selected for use.During unpacking, it was noted that the brake button on the advancer was broken.It could not be pressed and could not be taken out.The device was not used in the patient.The procedure was not completed due to this event.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.The brake button and advancer were microscopically and visually inspected.The advancer unit and burr units were received attached together as a single unit.The advancer knob was received loosened in a backward position.The brake button was received broken with a portion not returned.The returned portion of the brake button was received inside a sealed pouch and not attached to the advancer.The advancer housing was opened to check for damage or the missing portion of the brake.There was no damage to the advancer and the missing portion of the brake was not in the advancer.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
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Event Description
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It was reported that the brake defeat button was broken.A 1.25mm rotalink¿ plus was selected for use.During unpacking, it was noted that the brake button on the advancer was broken.It could not be pressed and could not be taken out.The device was not used in the patient.The procedure was not completed due to this event.No patient complications were reported.
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Search Alerts/Recalls
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