Model Number 8360-10 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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Event Description
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It was reported to aesculap inc.That a prestige atra grasper dbl-act 5mm (product # 8360-10) was used during a hysterectomy procedure on (b)(6) 2023.According to the complainant the jaw of the device had broken off during the procedure.No patient complications were reported as a result of this event.The adverse event is filed under aic reference (b)(4).
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Manufacturer Narrative
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Investigation results: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were not able to be reviewed as no lot number was made available.However, all device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.Conclusion and measures / preventative measures: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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Event Description
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Investigation complete.
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Manufacturer Narrative
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Corrected information - b1 - product problem only.
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Search Alerts/Recalls
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