Catalog Number 26-1221 |
Device Problem
Failure to Auto Stop (2938)
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Patient Problem
No Information (3190)
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Event Date 06/14/2017 |
Event Type
Injury
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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, a perforator did not disengage during use on patient.
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Manufacturer Narrative
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The affiliate was contacted regarding product returned; however, the product was not returned for evaluation.As such it is not possible to evaluate the product and determine the root cause of this complaint.A review of the device history records did not show any anomalies during the manufacturing process.We will continue to monitor for this or similar complaints for this product code.At this time this complaint is considered to be closed, should the product be returned at a later date this complaint will be re-opened and an investigation will be performed.
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Manufacturer Narrative
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It was previously noted that the device would not be returned for investigation; however, we have received the device.Upon completion of the investigation a follow-up report will be filed.
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Manufacturer Narrative
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Upon completion of the investigation it was noted that the product returned for evaluation.Visually inspected utilizing naked eye.No anomalies were observed.Unit was found to performed as intended.Unit completed testing (5 holes) and was found to performed as intended.The dhr was reviewed on 10/04/2017 and it was verified that there were no anomalies during the manufacturing process.Complaint could not be verified.Unit was found to meet all acceptance criteria.No further action is required.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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