Catalog Number 1011344-40 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that when the rx acculink was prepared for use, the tip separated when the stylet was removed.There was no patient involvement.Another device was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was returned.Visual inspections were performed on the returned device.The reported stretching was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported separation appears to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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