Model Number 701118090 |
Device Problems
Break (1069); Nonstandard Device (1420)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 10/08/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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Event Description
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The supercore needle fell apart during use.The doctor stabbed his hand with the broken device, left hand, little finger.No injury to patient.
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Manufacturer Narrative
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One opened device was returned for evaluation.Visual inspection found that the stylet was separated from the body of the device, with signs of the body having split open proximally.The complaint was confirmed.Argon medical devices has received other complaints that the supercore semi-automatic biopsy instrument is coming apart during or prior to use.Argon has conducted an internal investigation and tracked the affected parts to a narrow time frame resulting from a specific manufacturing event.The plastic housing and plunger can be separated more easily than normal for the lots manufactured during this time frame.Capa 2021-061 has been initiated to document our investigation into the cause of this problem and the corrective action that are being taken to prevent the re-occurrence of this problem.To ensure continued customer satisfaction, argon medical devices has decided to issue a voluntary recall of the affected lots because of the high rate of reports of unintentional disassembly of these devices.
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Event Description
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The supercore needle fell apart during use.The doctor stabbed his hand with the broken device, left hand, little finger.No injury to patient.
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Search Alerts/Recalls
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