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Catalog Number 26-1222 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Information (3190)
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Event Date 02/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Upon completion of the investigation, a follow up report will be filed.
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Event Description
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As reported by the ous affiliate, on 4 perforators, the labels detached from the devices when they were irrigated.The devices were replaced with like product; no patient adverse consequences were reported.The devices are being returned.Per rep, a delay of 20 minutes was reported.
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Manufacturer Narrative
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Upon completion of the investigation, it was noted that the evaluation revealed the following.Three perforators returned for evaluation.All 3 perforators had visible lot numbers on the label.Two had lot number: lj014s.Manufactured november 2016 at the (b)(4) facility.One had lot number cj003s manufactured march 2016 at the (b)(4) facility.All 3 had the product label rubbed off to some degree: one had the top 2/3rd partially rubbed off, adhesive still present.One had top ½ partially rubbed off, adhesive still present.One had middle 1/3 partially rubbed off, adhesive still present.All 3 appear to have been used.Visible apparent red blood and debris on inner and outer drill components.Unsure if ¿irrigation¿ is a standard practice and what it entails.Marks around the circumference of the label indicate the device was spinning.Appears some mechanical friction caused the labels to rub off in some areas.Does not appear that the label detached, adhesive present on all 3 perforators.The labels do not appear to have been defective.No cause can be found for the complaint.A review of the device history records for lj014s and cj003s did not reveal any anomalies during manufacturing processes.We will continue to monitor for this or similar complaints for this product code.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.
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Search Alerts/Recalls
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