Model Number 1816MSK |
Device Problems
Break (1069); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a biopsy procedure, the needle was allegedly bent upon insertion into site of biopsy.It was further reported that the needle was almost broke inside the patient.The procedure was completed using another device.There was no reported patient injury.
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Manufacturer Narrative
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The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, a photo and an image were provided for review.The investigation of the reported event is currently underway.
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Manufacturer Narrative
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H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.Device not returned.
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Event Description
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It was reported that during a computed tomography biopsy procedure, the needle was allegedly bent upon insertion into the site of biopsy.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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