Model Number 701118150 |
Device Problems
Break (1069); Nonstandard Device (1420); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2022 |
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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After the device was fired in the target area, when attempted to expose the specimen notch to collect biopsy sample, the housing broke and the plunger detached from the housing.Even though it was a very dangerous situation for the patient and the doctor, fortunately it did not harm anyone.Sugan check of the returned unit: the housing of the returned device was opened.The snap fit latch tabs were not broken, however, there seemed flash on the goose neck portion of the latch tab.
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Manufacturer Narrative
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A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.One opened device was returned for evaluation.Visual inspection found that the body of the device was split proximally with the spring released and the stylet separated out.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 the plastic housing and plunger can be separated more easily than normal.Capa (b)(6) has been opened to document our investigation into the cause of this problem and the corrective action that are being taken to ensure that this never happens again.
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Event Description
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After the device was fired in the target area, when attempted to expose the specimen notch to collect biopsy sample, the housing broke and the plunger detached from the housing.Even though it was a very dangerous situation for the patient and the doctor, fortunately it did not harm anyone.Sugan check of the returend unit: the housing of the returned device was opened.The snap fit latch tabs were not broken, however, there seemed flash on the goose neck portion of the latch tab.
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Search Alerts/Recalls
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