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Model Number 7100 |
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 an acessa procedure on (b)(6) 2023, the physician reported that experienced issues with the equipment not recognizing the handpiece, the physician was already inside the uterine cavity and was unable to get the handpiece recognized by the equipment during the procedure, they swapped the handpiece with no results.The procedure was aborted, and the patient rescheduled.No harm to the patient was reported.
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Manufacturer Narrative
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A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.H3: 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.
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Search Alerts/Recalls
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