Catalog Number 8065000095 |
Device Problems
Break (1069); Failure to Cut (2587)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 07/21/2021 |
Event Type
Injury
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that the tip of the probe broke and cutting failure occurred during a procedure.The condition of aspiration and actuation is unknown.The patient experienced bleeding from where the tip was dropped.The product was replaced with another one and the procedure was completed.
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Manufacturer Narrative
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A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, a device history record review could not be conducted.A sample was not received at the manufacturing site and no lot information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained; therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information received from company representative who indicated the patient recovered.
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Search Alerts/Recalls
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