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Model Number HB200 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that during a procedure on an unknown date , during a localizer procedure, the patient's injury was bracketed with two localizer tags , that both tags fell out of the excised specimen prior to intra-operative imaging so the physician had to close the patient and end the case.No other information is available at the moment.No lot number is available.No additional information was received.
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Manufacturer Narrative
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Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.Reports for both device involved under 3013649990-2021-00014.
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Search Alerts/Recalls
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