GYRUS ACMI, INC. GYRUS, PK-SP GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number 744000 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was observed that during the device evaluation, the generator exhibited damage to the superpulse board, and the plasma kinetic (pk) radio frequency was loose and damaged.There were no reports of patient involvement.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a definitive root cause could not be determined.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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