Model Number 8360-10 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
Injury
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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 two prestige atra grasper dbl-act 5mm (part # 8360-10) were used during a laparoscopic procedure on (b)(6) 2024.According to the complainant, during the procedure, the tip of the device broke off in the patient.A second prestige atra grasper dbl-act 5mm (part # 8360-10) (ref.Mdr id 2916714-2024-00076) was then used to retrieve the fragments, but the issue recurred.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.However, a five (5) minute surgical delay was reported.The adverse event is filed under aic reference xc (b)(4); cc( b)(4) reference associated medwatch report 2916714-2024-00076.
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Manufacturer Narrative
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Additional information h6 codes updated.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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Search Alerts/Recalls
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