GYRUS ACMI, INC. MULTIDEBRIDER POWER CONSOLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number MDCONS100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/01/2023 |
Event Type
Injury
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Event Description
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It was reported via a post-market clinical follow-up (pmcf) survey, the diego elite was used for soft tissue shaving of the head and neck.The diego elite performed adequately to cut, coagulate, drill, debride, and remove tissue for bone and soft tissue.The following adverse events were observed: bleeding: the bleeding occurred 2 to 7 days post procedure and the patient was re-hospitalized.The patient made a partial recovery to baseline.There were known comorbidities that may have attributed to the bleeding.Mucosal injury: the mucosal injury occurred 1 to 24 hours after the procedure and was managed clinically with additional medication.The patient made a full recovery to baseline at the time of hospital discharge.There were known comorbidities that may have attributed to the mucosal injury.Nasal symptoms: nasal symptoms occurred 8 to 14 days after the procedure requiring rehospitalization and additional medication.The patient made a partial recovery to baseline.There were known comorbidities that may have attributed to the nasal symptoms.Orbital injury: orbital injury occurred 2 to 7 days after the procedure that required re-hospitalization.The patient made a full recovery to baseline at the time of hospital discharge.There were known comorbidities that may have attributed to the orbital injury.
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Manufacturer Narrative
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B3: the exact event date is unknown, but the event occurred in august 2023.H6: health effect clinical code: code 4581 was chosen as there were no appropriate terms available for unspecified nasal symptoms and unspecified orbital injury.The device was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
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Manufacturer Narrative
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Although the exact age of the patient is unknown, it is known that the age falls within 18-34 years old.The device history record was unable to be reviewed for this device since the serial number was not provided.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 specific root cause of the suggested event could not be determined with the information received.Olympus will continue to monitor field performance for this device.
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