Model Number 370-1580-01 |
Device Problem
Defective Device (2588)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/04/2022 |
Event Type
Injury
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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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When the patient was performing liver puncture under the guidance of b-ultrasound, the biopsy needle was used.No tissue was taken from the puncture twice, only blood.Later, the puncture needle of other products was replaced successfully.The doctor believed that the condition prolonged the operation time and caused secondary injury to the patient, so he reported the incident to the competent authority.
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Event Description
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When the patient was performing liver puncture under the guidance of b-ultrasound, the biopsy needle was used.No tissue was taken from the puncture twice, only blood.Later, the puncture needle of other products was replaced successfully.The doctor believed that the condition prolonged the operation time and caused secondary injury to the patient, so he reported the incident to the competent authority.
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Manufacturer Narrative
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A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.A used sample was returned to argon from the customer.A visual inspection was performed on the returned sample.The visual inspection established that the cannula tips are bent inward and the pincer was slightly flattened, preventing the device from properly obtaining a sample.There are stringent computer/photographic inspections that ensure the cannula tri-tips and the pincer are not deformed during the manufacturing process.Additionally, the exact conditions of the biopsy performed in the user environment is not known.If the device is fired into either very fatty or some sort of calcified tissue then it is possible for the needle set components to bend out of shape and the pincer to have a failure when collecting a sample and resulting in an incomplete or no sample defect.Since the most likely cause for the damaged needles is related to an event within the user's environment and not a manufacturing issue, no corrective action can be implemented at this time.
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Search Alerts/Recalls
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