GYRUS ACMI, INC. CUT/FCP,5MM/33CM DES III (5/PK); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number 3006 |
Device Problems
Shipping Damage or Problem (1570); Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
Event Type
malfunction
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Event Description
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The customer reported to olympus, the cut/fcp, 5mm/33cm des iii (05/pk) was reported to fail upon installation; the sterile package was compromised.The bottom tab was broken off, and the other was crimped in.There were no reports of patient injury or medical intervention associated with this event.Related patient identifier: (b)(6) to capture the two other sterile packages that were compromised.
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Manufacturer Narrative
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The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event could not be determined although it can be presumed that the event occurred due to transportation mishandling, such as excessive force applied to the box during shipping or accidental dropping of the device packages.The event could have been detected/prevented by following the instructions for use: before surgery_1) carefully remove the device from its shipping package.Inspect to ensure no damage has occurred during transit or storage.Do not use this device if the packaging or device is damaged." olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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