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Model Number 8360-10 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2022 |
Event Type
Injury
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Event Description
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It was reported to aesculap inc.That a prestige atra grasper dbl-act 5mm (part # 8360-10) was used during a procedure performed on (b)(6) 2022.According to the complainant, during the procedure, the distal tip broke off and detached into the patient.The fragment was retrieved, and then the procedure was continued and successfully completed.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.The malfunction is filed under aag reference xc 100030734; cc 400554207.
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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Manufacturer Narrative
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Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.A visual examination of the device revealed that the distal jaw assembly had become disassembled.Additionally, both links were present at the distal tip, but a single grasper jaw was missing.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.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.The investigation into the cause of the reported problem was able to confirm the failure mode of distal jaw housing disassembled.In addition to a supplier corrective action request (scar) being initiated, a corrective action/preventive action (capa) was opened by aesculap inc.For further evaluation of the design transfer of this device.
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Search Alerts/Recalls
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